Package leaflet: Information for the patient

Myalepta 3 mg powder for injectable solution

metreleptin
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Myalepta is and what it is used for
What you need to know before using Myalepta
How to use Myalepta
Possible side effects
How to store Myalepta
Contents of the pack and other information

1. What Myalepta is and what it is used for

Myalepta contains the active substance metreleptin. Metreleptin is similar to a human hormone called leptin.
What Myalepta is used for
Myalepta is used to treat complications arising from insufficient levels of leptin in patients with lipodystrophy.
It is used in adults, adolescents, and children from 2 years of age affected by:

generalized lipodystrophy (the entire body lacks a sufficient amount of adipose tissue)

It is used, when other therapies have not been effective, in adults and adolescents from 12 years of age affected by:

hereditary partial lipodystrophy (also known as congenital or familial lipodystrophy)
or acquired partial lipodystrophy (also known as acquired lipodystrophy) caused by the body's response to an event such as a viral illness.

How Myalepta works
Natural leptin is produced by adipose tissue and performs many functions in the body, including:

regulating appetite and energy levels;
helping the insulin in the body manage blood sugar levels. Metreleptin works by mimicking the effects of leptin. This improves the body’s ability to regulate energy levels.

2. What you should know before using Myalepta

Do not use Myalepta

if you are allergic to metreleptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Myalepta:

if you are pregnant
if you have had a type of cancer called lymphoma
if you have had blood problems (such as low blood cell counts)
if you have had inflammation of an organ called the pancreas (pancreatitis)
if you have or have had disorders of the immune system (autoimmune diseases, including autoimmune liver problems)

Lymphoma
People with lipodystrophy may develop a type of blood cancer called lymphoma, regardless of whether or not they are using Myalepta.
However, when using this medicine, you may have an increased risk of developing lymphoma.
The decision on whether you should use Myalepta is made by your doctor, who will monitor you during this treatment.

Serious and life-threatening infections
During treatment with Myalepta, your body may produce antibodies that could increase the risk of developing serious and life-threatening infections. Inform your doctor immediately if you develop high fever accompanied by increasing fatigue (see section 4).

Low blood sugar levels with insulin or other antidiabetic medicines
If you are taking a medicine such as insulin or other medicines for the treatment of diabetes, your blood sugar will be closely monitored by your doctor. Your doctor will adjust the dose of insulin or other medicines, if necessary.
This will help prevent your blood sugar from becoming too low ("hypoglycemia"). For signs indicating low blood sugar, see section 4, under "Signs of high and low blood sugar".

High blood sugar levels and high blood fat levels
During treatment with Myalepta, you may have higher levels of sugar (hyperglycemia) or fat (hypertriglyceridemia) in your blood; this may indicate that this medicine is not working as expected. The signs of hyperglycemia and hypertriglyceridemia are listed in section 4, under "Signs of high and low blood sugar" and "Signs of high levels of fats in the blood".
If you notice any of these symptoms described above or in section 4 of this leaflet, or if you have any doubts, contact your doctor immediately. Your treatment may need to be adjusted.

Autoimmune diseases
People who have or have had disorders of the immune system (autoimmune diseases, including autoimmune liver problems) may experience worsening of symptoms with Myalepta. Talk to your doctor about which symptoms to watch for; the appearance of such symptoms should prompt further investigations.

Allergic reactions
During treatment with Myalepta, you may develop an allergic reaction. Inform your doctor immediately if you experience symptoms of an allergic reaction. The signs of an allergic reaction are listed in section 4, under "Allergic reactions".

Fertility
Myalepta may increase fertility in women with lipodystrophy (see section "Pregnancy, breastfeeding and fertility").

Myalepta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

Children and adolescents
Do not give this medicine to children under 2 years of age with generalized lipodystrophy or to children under 12 years of age with partial lipodystrophy. It is not known what effects this medicine may have in children below these age thresholds.

Other medicines and Myalepta
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Myalepta may affect how other medicines work. In addition, certain medicines may affect how this medicine works.
In particular, inform your doctor if you are taking any of the following medicines:

hormonal contraceptives, as Myalepta may reduce their effectiveness in preventing pregnancy
theophylline, used for lung diseases such as asthma
anticoagulants (such as warfarin or phenprocoumon)
medicines that suppress the immune system (such as cyclosporine)
antidiabetic medicines (such as insulin or insulin secretagogues), see section 2 'Low blood sugar levels with insulin or other antidiabetic medicines'

If you fall into any of the situations listed above (or have any doubts about them), talk to your doctor before using Myalepta. During treatment with Myalepta, certain medicines may require monitoring, as it may be necessary to adjust their dosage.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Myalepta if you are pregnant or could become pregnant. It is not known what effects Myalepta may have on the unborn child. Women of childbearing potential must use effective contraceptive methods, including non-hormonal methods such as condoms, during treatment with Myalepta. Discuss appropriate contraceptive methods with your doctor, as Myalepta may reduce the effectiveness of hormonal contraceptives in preventing pregnancy.
It is not known whether Myalepta passes into breast milk. Talk to your doctor if you are breastfeeding or planning to breastfeed. Together with your doctor, you will decide whether to continue or discontinue breastfeeding while being treated with this medicine, taking into account the benefits of breastfeeding for the child and the benefits of Myalepta for the mother.
Myalepta may increase fertility in women with lipodystrophy.

Driving and using machines
Myalepta has a minor influence on the ability to drive and use machines. You may experience dizziness or fatigue while being treated with this medicine. If this occurs, do not drive or operate tools or machinery. If you have any doubts, consult your doctor.

3. How to use Myalepta

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

Myalepta is administered by a subcutaneous injection (an injection under the skin) once daily. This medicine is used in children from 2 years of age, adolescents, and adults with generalized lipodystrophy, as well as in children from 12 years of age, adolescents, and adults with partial lipodystrophy.

During treatment with this medicine, your doctor will monitor you or the child and decide which dose should be used.
Your doctor may decide that you can self-inject the medicine. Your doctor, nurse, or pharmacist will show you how to prepare and inject this medicine yourself.

Do not try to prepare the medicine or inject it yourself unless you have been trained to do so.

How much medicine to inject

The dose of Myalepta may vary over time, depending on the effects achieved with this medicine. Myalepta powder is dissolved and mixed with water for injections to obtain the solution for injection. Read the “Instructions for use” explaining how to prepare the solution before injection.

Your doctor will prescribe the correct dose based on the following guidelines:

If you weigh 40 kg or less:
- Initial dose of 0.06 mg (0.012 ml of solution) per kilogram of body weight.
If you are male and weigh more than 40 kg:
- Initial dose of 2.5 mg (0.5 ml of solution).
If you are female and weigh more than 40 kg:
- Initial dose of 5 mg (1 ml of solution). Your doctor or pharmacist will inform you of the amount of solution to inject. If you have any doubts about the amount of solution to inject, consult your doctor or pharmacist before proceeding with the injection.
The syringe to use for injecting this medicine depends on the dose prescribed to you.
o Your pharmacist will provide the appropriate syringe for the injection.
o To determine which syringe to use, refer to the “Instructions for use”.
To determine the amount of medicine to inject (in ml), divide the dose (in mg) by 5.
o For example, if your doctor has prescribed a dose of Myalepta of 5 mg, 5 mg divided by 5 equals 1 ml, which corresponds to the amount of solution to inject using a 1 ml syringe.
If the dose is 1.50 mg (0.30 ml of solution) or less, a 0.3 ml syringe must be used.
o On the 0.3 ml syringe, the amount of solution to inject is indicated in “Units” instead of “ml”. Refer to the “Instructions for use” (section 7) for further information on how to read and use the different syringes.
o To determine the amount of solution to inject (in Units), divide the dose (in mg) by 5 and then multiply by 100.

If it is necessary to inject 1 ml or more of Myalepta solution, your doctor may instruct you to administer the dose as two separate injections. This may help make the injections more comfortable. For both injections, you must use a clean syringe and needle. If you have any doubts about the amount of solution to inject, consult your doctor or pharmacist before proceeding with the injection.

When small doses/volumes are prescribed (e.g., in children), vials remain almost completely full of product after the required dose has been withdrawn. Any reconstituted solution remaining after use must be discarded.

If you use more Myalepta than you should

If you use more Myalepta than prescribed, inform your doctor immediately or go to the hospital straight away. Your doctor will monitor you for any possible adverse effects.

If you forget to use Myalepta

If you forget to inject a dose, inject it as soon as you remember.
Then inject your next dose as usual the following day.
Do not inject a double dose to make up for the missed dose.

If you have injected less Myalepta than prescribed, inform your doctor immediately. Your doctor will monitor you for any possible adverse effects.

If you stop treatment with Myalepta

Do not stop treatment with Myalepta without first consulting your doctor. Your doctor will decide whether you should discontinue treatment with this medicine.

If it becomes necessary to stop treatment with Myalepta, your doctor will gradually reduce the dose over a period of two weeks before completely stopping therapy. Your doctor will also advise you to follow a low-fat diet.

Gradual dose reduction over two weeks is important because it may help prevent a sudden increase in fat levels (called “triglycerides”) in the blood.
A sudden increase in triglyceride levels in the blood may cause inflammation of the pancreas (pancreatitis). Gradual dose reduction, together with a low-fat diet, may help prevent this problem.

Do not stop treatment with Myalepta unless your doctor has instructed you to do so.

If you have any questions about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Possible side effects of this medicine:

Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment. If you are unable to contact your doctor, seek emergency medical assistance:

low blood sugar (glucose) level (hypoglycaemia), see the section “Signs of high and low blood sugar” below
high blood sugar (glucose) level (hyperglycaemia)
presence of a blood clot in a vein (venous thrombosis) – pain, swelling, warmth and redness, usually in the thigh or lower leg
fluid accumulation in the lungs – cough or difficulty breathing
feeling drowsy or confused

Allergic reactions
Contact your doctor immediately if you notice any severe allergic reaction, including:

breathing difficulties
skin swelling and redness, hives
swelling of the face, lips, tongue or throat
stomach pain, feeling unwell (nausea) and illness (vomiting)
fainting or feeling dizzy
severe stomach (abdominal) pain
very rapid heartbeat

Inflammation of the pancreas (pancreatitis):
Contact your doctor immediately if you notice signs of inflammation of the pancreas, including:

severe and sudden stomach (abdominal) pain
feeling unwell (nausea) or illness (vomiting)
diarrhoea

Other side effects
Contact your doctor if you notice any of the following side effects.
Very common (may affect more than 1 in 10 people):

weight loss

Common (may affect up to 1 in 10 people):

loss of interest in food
headache
hair loss
unusually heavy or prolonged menstrual periods
feeling tired
bruising, redness, itching or hives at the injection site
production by the body of antibodies against metreleptin, which may increase the risk of developing serious or life-threatening infections. You may notice the development of fever, accompanied by increased tiredness.

Frequency not known (frequency cannot be estimated from the available data):

influenza
chest infection
diabetes
increased appetite or overeating
faster than normal heartbeat
cough
shortness of breath
muscle pain (myalgia)
joint pain
swelling in hands and feet
increase in fatty tissue
swelling or bleeding under the skin at the injection site
pain at the injection site
itching at the injection site
general feeling of discomfort, malaise or widespread pain
increased levels of fat in the blood (triglycerides) (see section “Signs of high fat levels” below)
increased levels of glycated haemoglobin (HbA1c) in the blood, shown by blood tests
weight gain
swelling or bleeding under the skin (haemorrhage)
high blood sugar level (hyperglycaemia) (see section “Signs of high and low blood sugar” below). Contact your doctor if you notice any of the above side effects.

Signs of high and low blood sugar
Symptoms of low blood sugar levels include:

feeling dizzy
feeling drowsy or confused
clumsiness and dropping things
increased hunger
increased sweating
increased irritability or nervousness

If you notice any of these symptoms, or have any concerns, contact your doctor immediately: your treatment may need to be adjusted.
Symptoms of high blood sugar levels include:

excessive thirst or hunger
need to urinate more often than usual
feeling drowsy
feeling unwell or illness
blurred vision
chest or back pain
feeling short of breath

Signs of high fat levels
Symptoms of high fat levels include:

chest pain
pain under the ribs, like heartburn or indigestion
feeling unwell or illness

Contact your doctor if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Myalepta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the outer carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Keep the vial in its outer packaging to protect the medicine from light.
After reconstitution, the solution should be administered immediately and must not be stored for later use. Any unused medicine should be discarded.
Do not use this medicine if the solution appears cloudy, discoloured, or contains lumps or particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Myalepta contains

The active substance is metreleptin.
Each vial contains 3 milligrams of metreleptin. After reconstitution with 0.6 millilitres of water for injections, each millilitre of solution contains 5 milligrams of metreleptin.
The other components are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment).

Description of the appearance of Myalepta and contents of the pack
Myalepta is a powder for solution for injection (powder for injection). It is a white powder supplied in a
glass vial closed with a rubber stopper and sealed with an aluminium cap and a removable red plastic
cap.
Myalepta is available in packs containing 1 or 30 vials.
Not all pack sizes may be marketed in your country.
Your doctor, nurse, or pharmacist will supply syringes, needles, swabs, and water for injections
separately to allow you to prepare and administer Myalepta. You will also be provided with a “sharps
container” in which to dispose of used vials, syringes, and needles.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Amryt Pharmaceuticals DAC
45 Mespil Road
Dublin 4
Ireland

For further information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv ExCEEd Orphan s.r.o.
Tél/Tel: + 32 (0)2 788 42 00 Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

България Luxembourg/Luxemburg
ExCEEd Orphan s.r.o. Chiesi sa/nv
Bucharova 2657/12, Prague 5, 158 00 Tél/Tel: + 32 (0)2 788 42 00
Czech republic
Teл.: +359 888 918 090
[email protected]

Česká republika Magyarország
ExCEEd Orphan s.r.o. ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00 Bucharova 2657/12, Prague 5, 158 00
Czech republic Czech republic
Tel: +420 724 321 774 Tel.: +36 20 399 4269
[email protected] [email protected]

Danmark Malta
Chiesi Pharma AB Amryt Pharmaceuticals DAC
Tlf.: + 46 8 753 35 20 Tel: +44 1604 549952
[email protected]

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
ExCEEd Orphan s.r.o. Chiesi Pharma AB
Bucharova 2657/12, Prague 5, 158 00 Tlf: + 46 8 753 35 20
Czech republic
Tel.: +370 661 663 99
[email protected]

Ελλάδα Österreich
Amryt Pharmaceuticals DAC Chiesi Pharmaceuticals GmbH
Tηλ: +800 44 474447 Tel: + 43 1 4073919
Tηλ: +44 1604 549952
[email protected]

España Polska
Chiesi España, S.A.U. ExCEEd Orphan s.r.o.
Tel: + 34 93 494 8000 Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +48 502 188 023
[email protected]

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
ExCEEd Orphan Distribution d.o.o. ExCEEd Orphan s.r.o.
Savska cesta 32, Zagreb, 100 00 Bucharova 2657/12, Prague 5, 158 00
Croatia Czech republic
Tel: +385 99 320 0330 Tel: +40 744 366 015
[email protected] [email protected]

Ireland Slovenija
Chiesi Farmaceutici S.p.A. ExCEEd Orphan s.r.o.
Tel: + 39 0521 2791 Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +386 30 210 050
[email protected]

Ísland Slovenská republika
Chiesi Pharma AB ExCEEd Orphan s.r.o.
Sími: +46 8 753 35 20 Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +420 608 076 274
[email protected]

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Amryt Pharmaceuticals DAC Chiesi Pharma AB
Tηλ: +800 44 474447 Tel: +46 8 753 35 20
Tηλ: +44 1604 549952
[email protected]

Latvija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

This medicinal product has been authorised under “exceptional circumstances”. This means that, due to
the rarity of the disease, it has not been possible to obtain complete information about this medicinal
product. The European Medicines Agency will review annually any new information on this medicinal
product, and this package leaflet will be updated if necessary.

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .
In addition, links to other websites on rare diseases and their treatments are provided.

Instructions for use
Before using Myalepta, you must read sections 1–6 of this package leaflet and then read these
Instructions for use.
Before starting self-administration of this medicinal product at home, your doctor, nurse, or pharmacist
will instruct you on how to prepare and inject Myalepta. Contact them if you have any doubts or need
further information or assistance. Take the necessary time to carefully prepare and inject the medicinal
product, including the warming period of the vial after removal from the refrigerator, which is
approximately 20 minutes.

Additional training information
Additional information and explanatory videos are available to help you understand the correct use of
Myalepta. Contact your doctor to learn how to access this information.

Reading the syringe
Align the upper edge of the plunger with the mark corresponding to the prescribed dose. Examples for
syringes of various sizes are shown below. If the syringe looks different or has different markings,
consult your doctor, nurse, or pharmacist for further information.

Using the 0.3 mL syringe

On the 0.3 mL syringe, the amount of solution to be injected is indicated in “U” instead of “mL”.
“U” means “units”.
1 U equals 0.01 mL.
Every 5 U are marked by a number with a thicker line. This marking corresponds to 0.05 mL.
Every 1 U is marked by a shorter line between the thicker lines. This marking corresponds to 0.01 mL.
Every 0.5 U is marked by a short line between two lines indicating 1 U. This marking corresponds to 0.005 mL.

Two diagrams of syringes showing graduated scales with dosage markings: 0.06 ml corresponding to 6U, 0.12 ml to 12U, and 0.25 ml to 25U

To inject Myalepta solution using a small 0.3 mL syringe, the last column of the table below indicates the measurement in “units” on the syringe corresponding to the various doses of the medicinal product that may be prescribed by your doctor, nurse, or pharmacist.

Conversion of dose from “mL” to “units” using a 0.3 mL syringe

Child's weight	Myalepta dose	Volume of mixed Myalepta solution	Amount of mixed Myalepta solution to inject, expressed in "units" on the 0.3 mL syringe
9 kg	0.54 mg	0.10 mL	10
10 kg	0.60 mg	0.12 mL	12
11 kg	0.66 mg	0.13 mL	13
12 kg	0.72 mg	0.14 mL	14
13 kg	0.78 mg	0.15 mL	15
14 kg	0.84 mg	0.16 mL	16
15 kg	0.90 mg	0.18 mL	18
16 kg	0.96 mg	0.19 mL	19
17 kg	1.02 mg	0.20 mL	20
18 kg	1.08 mg	0.21 mL	21
19 kg	1.14 mg	0.22 mL	22
20 kg	1.20 mg	0.24 mL	24
21 kg	1.26 mg	0.25 mL	25
22 kg	1.32 mg	0.26 mL	26
23 kg	1.38 mg	0.27 mL	27
24 kg	1.44 mg	0.28 mL	28
25 kg	1.50 mg	0.30 mL	30

Using the 1 mL syringe

The amount of solution to be injected is marked in mL on this syringe, so you must inject the amount prescribed by your doctor, nurse, or pharmacist. There is no need to convert the amount from mL to units.
You will be provided with the 1 mL syringe if your daily dose is greater than 1.5 mg up to 5 mg, which in terms of volume corresponds to a Myalepta solution greater than 0.3 mL up to 1.0 mL.
Each 0.1 mL is indicated by a number with a long line.
Each 0.05 mL is indicated by a medium-length line.
Each 0.01 mL is indicated by a shorter line.

Two panels show markings on a syringe with red arrows indicating levels of 0.5 ml and 1 ml on the left, and 0.75 ml on the right

Using the 3.0 mL syringe

The amount of solution to be injected is marked in mL on this syringe, so you must inject the amount prescribed by your doctor, nurse, or pharmacist. There is no need to convert the amount from mL to units.
You will be provided with the 3.0 mL syringe if your daily dose is greater than 5 mg up to 10 mg, which in terms of volume corresponds to a Myalepta solution greater than 1.0 mL.
Each 0.5 mL is indicated by a long line.
Each 0.1 mL is indicated by a shorter line between the long lines.

Diagram of a syringe with a graduated scale indicating the 1.6 ml level, and a second syringe showing levels at 1.2 ml, 1.9 ml, and 3 ml

Step A - Preparation

Gather all the materials required for the injection, which have been provided by your doctor, nurse, or pharmacist. Place the following items on a clean, well-lit work surface:

one glass vial containing Myalepta powder
a container of water for injections, to dissolve the Myalepta powder. The water for injections may be supplied in glass or plastic vials, or in glass vials with a rubber stopper.
alcohol swabs (to disinfect the skin where the medicine will be injected and the tops of the vials)
sharps container (to safely dispose of used materials after the injection)

Two syringes will also be required:

One 1 mL syringe with a 40 mm, 21 gauge needle, to dissolve the powder
One injection syringe, equipped with a much shorter needle, to inject the solution subcutaneously. The size of this syringe will be determined by your doctor, nurse, or pharmacist based on your Myalepta dose.
o If the dose is 1.5 mg or less, the syringe to be used will be 0.3 mL.
o If the dose is greater than 1.5 mg up to 5 mg, the syringe to be used will be 1 mL.
o If the dose is greater than 5 mg, the syringe to be used will be 3.0 mL.
o If the dose is greater than 5 mg, your doctor, nurse, or pharmacist may advise administering the dose as two separate injections. See section 3 “How to use Myalepta” for more information.

Two syringes, two medicine vials, two packets of antiseptic wipes, and a yellow container for disposal of medical waste

Before preparing the Myalepta solution, allow the vial containing the powder to reach room temperature for approximately 10 minutes.

Clear glass vial containing white liquid next to a clock with a 10-minute interval highlighted in blue

Wash your hands before preparing the medicine.
Step B - Fill the 1 mL syringe with 0.6 mL of water for injections
Remove the 1 mL syringe from its plastic packaging. Always use a new syringe.

The 1 mL syringe and needle are supplied separately.
How to attach the needle to the syringe depends on the type of water for injections container provided: a plastic vial, a glass vial, or a glass vial with a rubber stopper (see below for specific instructions).

Draw up 0.6 mL of water for injections into the 1 mL syringe.
The water for injections will be provided by your doctor, nurse, or pharmacist along with the medicine vial and syringes. This water is mixed with the Myalepta powder so that the powder dissolves, turning the medicine into a liquid form suitable for injection. The water for injections may be supplied in one of the following containers:

a plastic vial
a glass vial
a glass vial (with rubber stopper). Always use a new vial or container of water for injections. Never use water for injections left over from preparing the Myalepta solution the previous day.

Water for injections in plastic vial

Line schematic drawing of a glass vial with stopper and security seal at the top on a white background

The plastic vial is a sealed container with a twist-off top.
To extract the water for injections, open the vial.

Hold the vial with the top facing upwards.
Hold the bottom of the vial with one hand and the top with the other hand.
Keeping the bottom of the vial steady, gently twist the top until it comes off.

Two illustrations show hands gently separating a transparent plastic container into two parts by applying central pressure

Do not attach the needle to the syringe.
Insert the tip of the 1 mL syringe (without attached needle) into the top of the plastic vial as far as possible.

With the syringe still inserted in the vial, turn the vial and syringe upside down. The syringe is now positioned with the tip facing upwards.
With the syringe still inserted in the vial, carefully pull the plunger down.

Pull down until the top edge of the plunger aligns with the black line indicating 0.6 mL.

A hand holds a syringe with a close-up showing the dosage of 0.6 ml indicated by a red line on the graduated scale

It is necessary to check whether there are air pockets or air bubbles in the 1 mL syringe. To remove air pockets or air bubbles from the syringe, refer to steps 6–8 below.
Detach the syringe from the plastic vial.

Attach the needle to the syringe.

Do not overtighten the needle.
Do not remove the protective needle cap.
Do not touch the needle.

Water for injections in glass vial

Schematic drawing of a glass vial containing a light blue liquid, with an indication of the break point on the narrow neck

The glass vial is a sealed container.
Before opening the vial containing the water for injections, prepare the 1 mL syringe by attaching the needle. Do not overtighten the needle.

Remove the protective needle cap.
Do not touch the needle.

To extract the water for injections, open the vial by snapping it at the break point, as shown in the figure below.

Hold the vial with the top facing upwards.
Disinfect the break point of the vial with an alcohol swab.
Hold the bottom of the vial with one hand and the top with the other hand.
Keeping the bottom of the vial steady, snap off the top.

Two illustrations show two hands gently removing a small transparent plastic cap from a white medical container

Insert the 1 mL syringe into the glass vial.

Tilt the glass vial at a 45-degree angle from the floor.
The needle should be inserted as far as possible into the vial.

With the needle still inserted in the vial, carefully pull the plunger upwards.

Pull the plunger upwards until the top edge of the plunger aligns with the black line indicating 0.6 mL.
It is necessary to check whether there are air pockets or air bubbles in the 1 mL syringe. To remove air pockets or air bubbles from the syringe, refer to steps 6–8 below.

A hand holds a syringe at an angle with a magnification showing the liquid level between the 0.6 and 0.7 marks on the graduated scale

Water for injections in glass vial with rubber stopper

Clear glass vial with gray cap containing a colorless liquid on white background with rounded green border

The glass vial has a plastic cap that must be removed to expose the underlying rubber seal.

Do not remove the rubber seal.

Attach the needle to the 1 mL syringe. Do not overtighten the needle.

Remove the protective needle cap.
Do not touch the needle.
Pull the plunger down to the line indicating 0.6 mL to draw air into the syringe.

Place the vial on a solid, flat surface.

Insert the needle of the 1 mL syringe into the vial through the rubber seal.
The needle should be directed downwards.
The needle must be fully inserted into the vial.

Push the plunger all the way down.

A hand holds a syringe vertically with a red arrow pointing downward indicating the direction of plunger pressure

With the needle still inserted in the vial, turn the vial and syringe upside down. The needle is now facing upwards.

Do not remove the needle from the vial.

Carefully pull the plunger down.

Pull the plunger down until the top edge of the plunger aligns with the black line indicating 0.6 mL.

A hand holds a syringe with a close-up showing the correct dosage between the 0.6 and 0.7 marks with a red arrow pointing downward

Regardless of whether you are drawing water for injections from a vial or a container, you must check that there are no air pockets or air bubbles in the 1 mL syringe.

Sometimes a large amount of air (an air pocket) may remain trapped inside the syringe. You may also see smaller air bubbles in the syringe.
It is necessary to remove the air pocket and air bubbles from the syringe to ensure that you have drawn up the correct amount of sterile water.

Remove any air pockets or air bubbles.
Using the glass vial or plastic vial

With the syringe still inserted in the glass vial or plastic vial, tap the side of the syringe gently to move the air pocket/bubbles to the top of the syringe.
Gently push the plunger upwards to expel the air from the syringe.

A hand holds a syringe with needle and liquid while the

Using the glass vial

Remove the syringe from the vial and hold it with the needle pointing upwards.
Tap the side of the syringe gently to move the air pocket/bubbles to the top of the syringe.
Gently push the plunger upwards to expel the air from the syringe.

Check the amount of water for injections.

If the amount of water for injections in the syringe is less than 0.6 mL, draw up more water for injections with the syringe and repeat steps 6 and 7 until the syringe contains 0.6 mL of water.

When the syringe contains 0.6 mL of water for injections, remove the syringe from the vial or container.

Do not move the plunger.
Do not touch the exposed needle of the syringe as it is sterile and you may damage the needle or injure yourself.

Step C - Dissolving Myalepta
10) Ensure that the vial containing Myalepta powder has been removed from the refrigerator for at least 10 minutes to reach room temperature.
11) Remove the plastic cap from the vial containing Myalepta powder.

Place the vial on a solid, flat surface.
Clean the top of the vial with an alcohol swab.

Fully insert the needle of the 1 mL syringe containing 0.6 mL of water for injections into the Myalepta vial containing the powder.

A hand holds a syringe vertically with liquid while the

Hold the vial at a 45-degree angle to the work surface and slowly push the plunger all the way down with your thumb.

The water for injections should flow down the inside wall of the vial.
Inject all the water for injections into the vial.

A hand holds a syringe with needle pointing downward while the

Remove the needle from the vial and dispose of the syringe in the sharps container.

A hand holds a syringe with needle pointing toward a glass vial held by

Mix the powder and water for injections.

Gently swirl the vial with circular (rotational) movements.
Continue until the powder dissolves and the liquid is clear. Do not shake or mix vigorously.
The solution will become clear within less than 5 minutes. When properly mixed, the Myalepta solution should be clear and free of dry powder clumps, bubbles, or foam. Do not use this medicine if the solution is not clear or contains clumps or particles. Discard it and restart the procedure from step 1.

A hand rotates three glass vials containing transparent liquid and a single isolated vial on white background with green borders

Step D - Fill the syringe with Myalepta for injection
16) To inject the Myalepta solution, use a new injection syringe, which will be a 0.3 mL, 1.0 mL, or 3.0 mL syringe provided by your doctor, nurse, or pharmacist. Remove the protective needle cap.

Do not touch the needle.
Do not move the plunger.

Fully insert the needle into the vial containing the dissolved Myalepta solution, through the center of the rubber stopper.

Syringe with needle inserted into the rubber stopper of a glass vial containing a light blue liquid on a white background

With the needle inserted in the vial, turn the vial and syringe upside down.

Two hands hold a syringe with needle inserted into a glass vial to draw up medicinal liquid with visible graduated markings

Keeping the needle inside the vial, pull the plunger down.

The top edge of the plunger must align with the black line on the syringe corresponding to the amount of Myalepta solution to be injected.

A hand holds a syringe with a red indicator pointing downward to indicate pressure on the plunger for

Check that there are no air pockets or air bubbles.

If you notice an air pocket or air bubbles, follow the same instructions as in step 7 to remove the air from the syringe.

If the syringe contains the correct dose of Myalepta solution, remove the needle from the vial.

Do not move the plunger.
Do not touch the needle.

Step E - Choose and prepare the injection site
22) Carefully choose the site where you intend to inject Myalepta. This medicine may be injected in the following areas:

stomach area (abdomen), except for a 5 cm area around the navel
thighs
upper arm, on the back side

Diagram of two male human figures showing orange-colored injection sites on

If you plan to use the same body area for each injection, avoid the site used for the last injection.

If you are injecting other medicines, do not inject Myalepta at the same site where other medicines were injected.

Clean the selected injection site with a clean alcohol swab and allow the skin to dry.

Avoid touching the cleaned area before administering the Myalepta injection.

Step F - Injecting Myalepta
Important: Myalepta must be injected under the skin (“subcutaneous use”). Do not inject the medicine into a muscle.
24) To perform a subcutaneous injection, pinch the skin at the injection site with one hand.

A hand grasps and lifts a fold of skin and subcutaneous tissue to prepare the area for

Hold the syringe in the other hand, as if holding a pen.
Gently insert the needle into the skin at an angle of approximately 45 degrees to the body.

Do not insert the needle into the muscle.
The needle is short and should fully penetrate the skin at a 45-degree angle.

A hand holds an injection pen tilted at a 45-degree angle while inserting the

Gently push the plunger down with your thumb until it is fully depressed.
o Inject all the medicine.
o If any medicine remains in the syringe, the full dose has not been administered.

A hand holds a syringe vertically with liquid in

Remove the syringe from the skin.
Step G - Disposal of used materials
Immediately dispose of both used syringes and all caps, vials, or vials in the sharps container.
o When the sharps container is full, contact your doctor, nurse, or pharmacist for proper disposal. There may be local regulations regarding disposal.

Two syringes with orange liquid and two glass vials fall toward

Important
o Do not use syringes more than once. Always use new syringes each time.
o Vials may remain almost completely full of product after withdrawing the required dose. The remaining solution must be discarded after use.
o Do not dissolve another dose of Myalepta powder with unused water for injections remaining in a vial or container. This unused water for injections must be discarded in the sharps container. Always use a new vial or container of water for injections each time you prepare to dissolve Myalepta powder.
o Do not recycle syringes, caps, or the sharps container, and do not dispose of these materials in household waste.
o Always keep the sharps container out of the reach of children.

Patient information leaflet

Myalepta 5.8 mg powder for solution for injection

metreleptin
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Myalepta is and what it is used for
What you need to know before using Myalepta
How to use Myalepta
Possible side effects
How to store Myalepta
Contents of the pack and other information

1. What Myalepta is and what it is used for

Myalepta contains the active substance metreleptin. Metreleptin is similar to a human hormone called leptin.

What Myalepta is used for
Myalepta is used to treat complications arising from insufficient levels of leptin in patients with lipodystrophy.
It is used in adults, adolescents, and children from 2 years of age affected by:

generalized lipodystrophy (the entire body lacks a sufficient amount of adipose tissue)

It is used, when other therapies have not been effective, in adults and adolescents from 12 years of age affected by:

inherited partial lipodystrophy (also called congenital or familial lipodystrophy)
or acquired partial lipodystrophy (also called acquired lipodystrophy) caused by the body's response to an event such as a viral illness.

How Myalepta works
Naturally occurring leptin is produced by adipose tissue and performs many functions in the body, including:

regulating appetite and energy levels;
helping the insulin in the body manage blood sugar levels. Metreleptin works by mimicking the effects of leptin. This improves the body’s ability to regulate energy levels.

2. What you need to know before using Myalepta

Do not use Myalepta

if you are allergic to metreleptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Myalepta:

if you are pregnant
if you have had a type of cancer called lymphoma
if you have had blood problems (such as low blood cell counts)
if you have had inflammation of an organ called the pancreas (pancreatitis)
if you have or have had disorders of the immune system (autoimmune diseases, including autoimmune liver problems)

Lymphoma
People with lipodystrophy may develop a type of blood cancer called lymphoma, regardless of whether or not they use Myalepta.
However, when using this medicine, you may have an increased risk of developing lymphoma.
The decision on whether you should use Myalepta will be made by your doctor, who will monitor you during treatment.

Serious and life-threatening infections
During treatment with Myalepta, your body may produce antibodies that could increase the risk of developing serious and life-threatening infections. Immediately inform your doctor if you develop high fever accompanied by increasing fatigue (see section 4).

Low blood sugar levels with insulin or other antidiabetic medicines
If you are using a medicine such as insulin or other antidiabetic medicines, your blood sugar will be closely monitored by your doctor. Your doctor will adjust the dose of insulin or other medicines, if necessary.
This will help prevent your blood sugar from becoming too low ("hypoglycemia"). For signs indicating low blood sugar, see section 4, under "Signs of high and low blood sugar".

High blood sugar levels and high blood fat levels
During treatment with Myalepta, you may have higher levels of sugar (hyperglycemia) or fat (hypertriglyceridemia) in your blood; this may indicate that the medicine is not working as expected. Signs of hyperglycemia and hypertriglyceridemia are listed in section 4, under "Signs of high and low blood sugar" and "Signs of high levels of fats in the blood".
If you notice any of these symptoms described above or in section 4 of this leaflet, or if you have any doubts, contact your doctor immediately. Your treatment may need to be adjusted.

Allergic reactions
During treatment with Myalepta, you may develop an allergic reaction. Immediately inform your doctor if you experience symptoms of an allergic reaction. Signs of an allergic reaction are described in section 4, under "Allergic reactions".

Fertility
Myalepta may increase fertility in women with lipodystrophy (see section "Pregnancy, breastfeeding and fertility").

Myalepta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

Children and adolescents
Do not give this medicine to children under 2 years of age with generalized lipodystrophy or to children under 12 years of age with partial lipodystrophy. The effects of this medicine in children below these age thresholds are not known.

Other medicines and Myalepta
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Myalepta may affect how other medicines work. Also, some medicines may affect how this medicine works.
In particular, inform your doctor if you are taking any of the following medicines:

hormonal contraceptives, because Myalepta may reduce their effectiveness in preventing pregnancy
theophylline, used for lung diseases such as asthma
anticoagulants (such as warfarin or phenprocoumon)
medicines that suppress the immune system (such as cyclosporine)
antidiabetic medicines (such as insulin or insulin secretagogues); see section 2, 'Low blood sugar levels with insulin or other antidiabetic medicines'

If you are in any of the situations listed above (or have any doubts about this), talk to your doctor before using Myalepta. During treatment with Myalepta, some medicines need to be monitored, as dose adjustments may be necessary.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Myalepta if you are pregnant or could become pregnant. The effects of Myalepta on the unborn child are not known. Women who can become pregnant must use effective contraceptive methods, including non-hormonal methods such as condoms, during treatment with Myalepta. Discuss appropriate contraceptive methods with your doctor, as Myalepta may reduce the effectiveness of hormonal contraceptives in preventing pregnancy.
It is not known whether Myalepta passes into breast milk. Talk to your doctor if you are breastfeeding or planning to breastfeed. Together with your doctor, you will decide whether to continue or stop breastfeeding while being treated with this medicine, taking into account the benefits of breastfeeding for the child and the benefits of Myalepta for the mother.
Myalepta may increase fertility in women with lipodystrophy.

3. How to use Myalepta

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

During treatment with this medicine, your doctor will monitor you or your child and decide which dose should be used.

Your doctor may decide that you can self-inject the medicine. Your doctor, nurse, or pharmacist will show you how to prepare and inject this medicine yourself.

Do not try to prepare the medicine or inject it yourself unless you have been trained to do so.

How much medicine to inject

The dose of Myalepta may vary over time depending on the effects achieved with this medicine. The Myalepta powder is dissolved and mixed with water for injections to obtain the solution for injection. Read the “Instructions for Use” that explain how to prepare the solution before injection.

Your doctor will prescribe the correct dose based on the following guidelines:

If you weigh 40 kg or less:
- Initial dose of 0.06 mg (0.012 mL of solution) per kilogram of body weight.
If you are male and weigh more than 40 kg:
- Initial dose of 2.5 mg (0.5 mL of solution).
If you are female and weigh more than 40 kg:
- Initial dose of 5 mg (1 mL of solution). Your doctor or pharmacist will inform you of the amount of solution to inject. If you have any doubts about the amount of solution to inject, consult your doctor or pharmacist before proceeding with the injection.
The syringe to use for injecting this medicine depends on the dose prescribed to you.
- Your pharmacist will provide you with the appropriate syringe for the injection.
- To determine which syringe to use, refer to the “Instructions for Use”.
To determine the amount of medicine to inject (in mL), divide the dose (in mg) by 5.
- For example, if your doctor has prescribed a dose of Myalepta of 5 mg, 5 mg divided by 5 equals 1 mL, which corresponds to the amount of solution to inject using a 1 mL syringe.
If the dose is 1.50 mg (0.30 mL of solution) or less, a 0.3 mL syringe must be used.
- On the 0.3 mL syringe, the amount of solution to inject is indicated in “Units” instead of “mL”. Refer to the “Instructions for Use” (section 7) for further information on how to read and use the different syringes.
- To determine the amount of solution to inject (in Units), divide the dose (in mg) by 5 and then multiply by 100.

If it is necessary to inject 1 mL or more of the Myalepta solution, your doctor may instruct you to administer the dose as two separate injections. This may help make the injections more comfortable. For both injections, you must use a clean syringe and needle. If you have any doubts about the amount of solution to inject, consult your doctor or pharmacist before proceeding with the injection.

When small doses/volumes are prescribed (e.g., in children), the vials remain almost completely full after the required dose has been withdrawn. Any reconstituted solution remaining after use must be discarded.

If you use more Myalepta than you should

If you use more Myalepta than you should, inform your doctor immediately or go to hospital straight away. Your doctor will monitor you for any possible side effects.

If you forget to use Myalepta

If you forget to inject a dose, inject it as soon as you remember.
Then inject your next dose as usual the following day.
Do not use a double dose to make up for the forgotten dose.

If you have injected less Myalepta than you should have, inform your doctor immediately. Your doctor will monitor you for any possible side effects.

If you stop using Myalepta

Do not stop treatment with Myalepta without first consulting your doctor. Your doctor will decide whether you should stop treatment with this medicine.

If it becomes necessary to stop treatment with Myalepta, your doctor will gradually reduce the dose over a period of two weeks before stopping the treatment completely. Your doctor will also advise you to follow a low-fat diet.

Gradual dose reduction over two weeks is important because it may help prevent a sudden increase in fat levels (called “triglycerides”) in the blood.
A sudden increase in triglyceride levels in the blood may cause inflammation of the pancreas (pancreatitis). Gradual dose reduction, together with a low-fat diet, may help prevent this problem.

Do not stop treatment with Myalepta unless your doctor has told you to do so.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects of this medicine:

low blood sugar (glucose) levels (hypoglycaemia) – see the section “Signs of high and low blood sugar” below
high blood sugar (glucose) levels (hyperglycaemia)
presence of a blood clot in a vein (venous thrombosis) – pain, swelling, warmth, and redness, usually in the thigh or lower leg
fluid accumulation in the lungs – cough or difficulty breathing
feeling drowsy or confused

Allergic reactions
Contact your doctor immediately if you notice any severe allergic reaction, including:

breathing difficulties
skin swelling and redness, hives
swelling of the face, lips, tongue, or throat
stomach pain, feeling unwell (nausea), and feeling unwell (vomiting)
fainting or feeling dizzy
severe stomach (abdominal) pain
very rapid heartbeat

Inflammation of the pancreas (pancreatitis):
Contact your doctor immediately if you notice signs of inflammation of the pancreas, including:

severe and sudden pain in the stomach (abdomen)
feeling unwell (nausea) or being unwell (vomiting)
diarrhoea

Other side effects
Contact your doctor if you notice any of the following side effects.
Very common (may affect more than 1 in 10 people):

weight loss

Common (may affect up to 1 in 10 people):

loss of appetite
headache
hair loss
unusually heavy or prolonged menstrual periods
feeling tired
bruising, redness, itching, or hives at the injection site
production by the body of antibodies against metreleptin, which may increase the risk of developing severe or life-threatening infections. You may notice the development of fever, accompanied by increased tiredness.

Frequency not known (frequency cannot be estimated from the available data):

influenza
chest infection
diabetes
increased appetite or eating excessively
faster than normal heartbeat
cough
shortness of breath
muscle pain (myalgia)
joint pain
swelling of the hands and feet
increase in fatty tissue
swelling or bleeding under the skin at the injection site
pain at the injection site
itching at the injection site
general feeling of discomfort, malaise, or generalized pain
increased levels of fat (triglycerides) in the blood (see the section “Signs of high fat levels” below)
increased levels of glycated haemoglobin (HbA1c) in the blood, as shown by blood tests
weight gain
swelling or bleeding under the skin (haemorrhage)
high blood sugar (hyperglycaemia) (see the section “Signs of high and low blood sugar” below). Contact your doctor if you notice any of the side effects listed above.

Signs of high and low blood sugar
Symptoms of low blood sugar levels include:

feeling dizzy
feeling drowsy or confused
clumsiness and dropping things
hunger greater than normal
sweating more than normal
increased irritability or nervousness

If you notice any of these symptoms, or have any concerns, contact your doctor immediately – your treatment may need to be adjusted.
Symptoms of high blood sugar levels include:

extreme thirst or hunger
need to urinate more often than usual
feeling drowsy
feeling unwell or being unwell
blurred vision
chest or back pain
feeling short of breath

Signs of high fat levels
Symptoms of high fat levels include:

chest pain
pain under the ribs, like heartburn or indigestion
feeling unwell or being unwell

Contact your doctor if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Myalepta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the outer carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Keep the vial in the outer packaging to protect the medicine from light.
After reconstitution, the solution should be administered immediately and must not be stored for later use. Any unused medicine should be discarded.
Do not use this medicine if the solution appears cloudy, discoloured, or contains lumps or particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Myalepta contains

The active substance is metreleptin. Each vial contains 5.8 milligrams of metreleptin. After dissolving the contents of the vial in 1.1 millilitres of water for injection, each millilitre of solution contains 5 milligrams of metreleptin.
The other ingredients are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment).

Description of the appearance of Myalepta and contents of the pack
Myalepta is a powder for solution for injection. It is a white powder supplied in a glass vial closed with a rubber stopper and an aluminium seal with a removable blue plastic cap.
Myalepta is available in packs containing 1 or 30 vials.
Not all pack sizes may be marketed in your country.
Your doctor, nurse or pharmacist will provide separately the syringes, needles, swabs and water for injection needed to prepare and administer Myalepta. You will also be given a “sharps disposal container” in which you must place used vials, syringes and needles.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Amryt Pharmaceuticals DAC
45 Mespil Road
Dublin 4
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: