Saphnelo

Package leaflet: Information for the patient

Saphnelo 300 mg concentrate for solution for infusion

anifrolumab
This medicinal product is subject to additional monitoring. This will allow rapid 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 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 or nurse.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Saphnelo is and what it is used for
2. What you need to know before using Saphnelo
3. How to use Saphnelo
4. Possible side effects
5. How to store Saphnelo
6. Contents of the pack and other information

1. What Saphnelo is and what it is used for

What Saphnelo is
Saphnelo contains the active substance anifrolumab, a "monoclonal antibody" (a type of protein
specialised in binding to a specific target in the body).

What Saphnelo is used for
Saphnelo is used to treat moderate to severe lupus (systemic lupus erythematosus, SLE) in adults
whose disease is not well controlled with standard therapies ("oral corticosteroids", "immunosuppressants",
and/or "antimalarials").
You will be given Saphnelo in addition to standard lupus therapy.
Lupus is a disease in which the immune system (the system that fights infections) attacks the body's
own cells and tissues. This causes inflammation and organ damage. It can affect almost any organ in
the body, including the skin, joints, kidneys, brain, and other organs. It may cause pain, skin rashes,
joint swelling, fever, and extreme tiredness or weakness.

How Saphnelo works
People with lupus have high levels of proteins called "type 1 interferons" that stimulate immune system
activity. Anifrolumab binds to a target (receptor) where these proteins act, thereby interrupting their
function. By blocking their action in this way, Saphnelo may reduce the inflammation causing lupus
symptoms in your body.

Benefits of using Saphnelo
Saphnelo can help reduce lupus disease activity and decrease the number of flare-ups.
If you are taking medicines called "oral corticosteroids", using Saphnelo may also allow your doctor
to reduce the daily oral corticosteroid dose needed to help control your lupus.

2. What you should know before using Saphnelo

Do not use Saphnelo

• if you are allergic to anifrolumab or to any of the other ingredients of this medicine (listed in section 6). If you have any doubts, consult your doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before using Saphnelo:

• if you think you have ever had an allergic reaction to this medicine at any time (see below “Be aware of signs of allergic reactions and serious infections”).
• if you think you have an infection or if you develop symptoms of an infection (see below under “Be aware of signs of allergic reactions and serious infections”).
• if you have a long-lasting infection or if you have an infection that keeps recurring.
• if lupus affects your kidneys or nervous system.
• if you have or have had cancer.
• if you have recently received a vaccination (vaccine) or plan to receive one. You must not receive certain types of vaccines (‘live’ or ‘attenuated’ vaccines) while being treated with this medicine.
• if you are receiving another biological medicine (such as belimumab for your lupus).

If you are unsure whether any of the conditions described above apply to you, talk to your doctor or
nurse before receiving Saphnelo.
Be aware of signs of allergic reactions and serious infections
Saphnelo can cause serious allergic reactions (anaphylaxis), see section 4. Contact your doctor immediately
if you suspect you are having a serious allergic reaction. Signs may include:

• swelling of the face, tongue, or mouth
• difficulty breathing
• feeling faint, dizzy, or lightheaded (due to a drop in blood pressure).

You may be at higher risk of developing an infection while being treated with Saphnelo. Inform your doctor or nurse as soon as possible if you notice signs of any possible infection, including:

• fever or flu-like symptoms
• muscle aches
• cough or shortness of breath (these may be signs of an airway infection, see section 4)
• burning sensation when urinating or more frequent urination than usual
• diarrhoea or stomach pain
• a red rash that may be painful and cause burning (this could be a sign of shingles, see section 4).

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it has not been studied in patients of this age group.
Other medicines and Saphnelo

• Inform your doctor if you are taking, have recently taken, or might take any other medicines.
• Inform your doctor if you have recently received or are due to receive a vaccination. You must not receive certain types of vaccines while using this medicine. If you are unsure, consult your doctor or nurse before and during treatment with Saphnelo.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
Pregnancy
It is not known whether Saphnelo can harm an unborn baby.

• Before starting treatment with Saphnelo, inform your doctor if you are pregnant or think you might be. Your doctor will decide whether this medicine can be given to you.
• Talk to your doctor if you are planning a pregnancy during treatment with this medicine.
• If you become pregnant while being treated with Saphnelo, inform your doctor. They will discuss with you whether you should stop treatment with this medicine.

Breastfeeding

• If you are breastfeeding, inform your doctor before starting treatment with Saphnelo. It is not known whether this medicine is excreted in breast milk. Your doctor will advise you whether you should stop treatment with this medicine while breastfeeding, or whether you should stop breastfeeding.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Saphnelo contains polysorbate
This medicine contains 1 mg of polysorbate 80 (E 433) per vial, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Saphnelo

A nurse or doctor will administer Saphnelo to you.

• The recommended dose is 300 mg.
• It is given as an intravenous infusion (into a vein) over approximately 30 minutes.
• It is administered every 4 weeks.

If you miss an appointment to receive Saphnelo, contact your doctor as soon as possible to schedule
another appointment.
If you stop treatment with Saphnelo
Your doctor will decide whether you need to stop treatment with this medicine.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Severe allergic reactions:
Severe allergic reactions ( anaphylaxis ) are not uncommon (may affect up to 1 in 100 people). Contact a doctor immediately or go to the nearest emergency room if you develop any of the following signs of a severe allergic reaction:

• swelling of the face, tongue or mouth
• difficulty breathing
• feeling faint, dizzy or lightheaded (due to a drop in blood pressure).

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

• nose or throat infections
• chest infection ( bronchitis )

Common (may affect up to 1 in 10 people)

• sinus or lung infections
• shingles ( herpes zoster ): a red rash that may cause pain and burning
• allergic reactions ( hypersensitivity )
• infusion reactions: may occur during or shortly after the infusion; symptoms may include headache, nausea, vomiting, feeling extremely tired or weak ( fatigue ), and dizziness

Not known (frequency cannot be estimated from the available data)

• joint pain ( arthralgia )

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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 Saphnelo

Your doctor, nurse or pharmacist is responsible for storing this medicine. The storage information is as follows:

• Do not use this medicine after the expiry date stated on the vial label and on the carton after Exp. The expiry date refers to the last day of that month.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C - 8 °C).
• Do not freeze, shake or expose to heat.
• Keep the vial in the original packaging to protect the medicine from light.

6. Package contents and other information

What Saphnelo contains

• The active substance is anifrolumab. Each vial contains 300 mg of anifrolumab.
• The other components are histidine, monohydrochloride monohydrate of histidine, lysine hydrochloride, trehalose dihydrate, polysorbate 80 (E 433) (see section 2 “Saphnelo contains polysorbate”) and water for injections.

Description of the appearance of Saphnelo and contents of the pack
Saphnelo is supplied as a concentrated solution, from clear to opalescent, colourless to slightly yellow.
Saphnelo is available in packs containing 1 vial.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

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

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

To improve traceability, the name and batch number of the administered medicinal product must
be clearly documented.
Saphnelo is supplied as a single-dose vial. The infusion solution must be prepared and
administered by a healthcare professional using the following aseptic technique:
Preparation of the solution

1. Visually inspect the vial for particulate matter and discoloration. Saphnelo is a solution ranging from clear to opalescent, colorless to slightly yellow. Discard the vial if the solution is cloudy, discolored, or contains visible particles. Do not shake the vial.
2. Dilute 2.0 mL of Saphnelo infusion solution into a 50 mL or 100 mL infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection.
3. Mix the solution gently by inverting the bag several times. Do not shake.
4. Any concentrate remaining in the vial must be discarded.
5. From a microbiological standpoint, the medicinal product should be used immediately after dilution. If not used immediately, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C or for 4 hours at room temperature. Discard the diluted solution if not used within these timeframes.

If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
Administration

1. The infusion solution should be administered immediately after preparation. If the infusion solution has been refrigerated, allow it to reach room temperature (15 °C – 25 °C) before administration.
2. Administer the infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, low protein-binding in-line filter of 0.2 to 15 microns or an additional filter.
3. At the end of the infusion, flush the infusion set with 25 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure that the entire infusion solution has been delivered.
4. Do not co-administer other medicinal products through the same infusion line.

Disposal
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Patient Information Leaflet

Saphnelo 1 20 mg solution for injection in pre-filled syringe

anifrolumab
This medicinal product is subject to additional monitoring. This will allow for rapid 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 this leaflet carefully before 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, nurse or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.

Contents of this leaflet

1. What Saphnelo is and what it is used for
2. What you need to know before using Saphnelo
3. How to use Saphnelo
4. Possible side effects
5. How to store Saphnelo
6. Contents of the pack and other information

1. What Saphnelo is and what it is used for

What Saphnelo is
Saphnelo contains the active substance anifrolumab, a “monoclonal antibody” (a type of protein
specialised in binding to a specific target in the body).

What Saphnelo is used for
Saphnelo is used for the treatment of moderate to severe lupus (systemic lupus erythematosus, SLE)
in adults whose disease is not well controlled with standard therapies (“oral corticosteroids”,
“immunosuppressants” and/or “antimalarials”).
You will be given Saphnelo in addition to standard lupus therapy.
Lupus is a disease in which the immune system (the system that fights infections) attacks the body's
own cells and tissues. This causes inflammation and organ damage. It can affect almost any organ in
the body, including the skin, joints, kidneys, brain and other organs. It can cause pain, skin rashes,
joint swelling, fever and a feeling of extreme tiredness or weakness.

How Saphnelo works
People with lupus have high levels of proteins called “type 1 interferons” that stimulate immune system
activity. Anifrolumab binds to a target (receptor) through which these proteins act, thereby blocking
their activity. By blocking their action in this way, Saphnelo may reduce the inflammation causing
lupus symptoms in your body.

Benefits of using Saphnelo
Saphnelo can help reduce lupus disease activity and decrease the number of flare-ups.
If you are taking medicines called “oral corticosteroids”, using Saphnelo may also allow your doctor to
reduce the daily oral corticosteroid dose needed to help control your lupus.

2. What you need to know before using Saphnelo

Do not use Saphnelo

• if you are allergic to anifrolumab or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before using Saphnelo:

• if you think you have ever had an allergic reaction to this medicine (see section below “Be aware of signs of allergic reactions and serious infections”).
• if you think you have an infection or if you develop symptoms of an infection (see section below “Be aware of signs of allergic reactions and serious infections”).
• if you have a long-lasting infection or if you have an infection that keeps recurring.
• if lupus affects your kidneys or nervous system.
• if you have or have had cancer.
• if you have recently received a vaccination (vaccine) or plan to receive one. You must not receive certain types of vaccines (‘live’ or ‘attenuated’ vaccines) while being treated with this medicine.
• if you are receiving another biological medicine (such as belimumab for lupus).

If you are unsure whether any of the conditions described above apply to you, talk to your doctor or
nurse before using Saphnelo.
Be aware of signs of allergic reactions and serious infections
Saphnelo may cause serious allergic reactions (anaphylaxis), see section 4. Contact your doctor
immediately if you think you are having a serious allergic reaction. Signs may include:

• swelling of the face, tongue, or mouth
• difficulty breathing
• feeling faint, dizzy, or lightheaded (due to a drop in blood pressure).

You may be at higher risk of developing an infection while being treated with Saphnelo. Inform your
doctor or nurse as soon as possible if you notice signs of any possible infection, including:

• fever or flu-like symptoms
• muscle aches
• cough or shortness of breath (these may be signs of a respiratory tract infection, see section 4)
• burning sensation when urinating or urinating more frequently than usual
• diarrhoea or stomach pain
• a red rash that may be painful and cause burning (this may be a sign of shingles, see section 4).

Each time you receive a new pack of Saphnelo

• Write down the name and batch number shown on the outer carton and on the label of the pre-filled syringe, and keep this information in a safe place. You may need to provide this information in the future.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it has not been studied
in patients of this age group.
Other medicines and Saphnelo

• Inform your doctor if you are taking, have recently taken, or might take any other medicines.
• Inform your doctor if you have recently received or are due to receive a vaccination. You must not receive certain types of vaccines while using this medicine. If you are unsure, consult your doctor or nurse before and during treatment with Saphnelo.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before taking this medicine.
Pregnancy
It is not known whether Saphnelo can harm the unborn baby.

• Before starting treatment with Saphnelo, inform your doctor if you are pregnant or think you might be. Your doctor will decide whether this medicine can be given to you.
• Talk to your doctor if you are planning a pregnancy during treatment with this medicine.
• If you become pregnant while being treated with Saphnelo, inform your doctor. Your doctor will discuss with you whether you should stop treatment with this medicine.

Breastfeeding

• If you are breastfeeding, inform your doctor before starting treatment with Saphnelo. It is not known whether this medicine is excreted in breast milk. Your doctor will advise you whether you should stop treatment with this medicine while breastfeeding, or whether you should stop breastfeeding.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.
Saphnelo contains polysorbate
This medicine contains 0.4 mg of polysorbate 80 (E 433) in each pre-filled syringe, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Saphnelo

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
The recommended dose is 120 mg once weekly. Saphnelo is administered as an injection under the skin (subcutaneously).
Your doctor or nurse will decide whether you are able to self-administer the medicine or if it can be given by a caregiver.

Before injecting Saphnelo

• Your doctor or nurse must train you or your caregiver on how to correctly use the Saphnelo pre-filled syringe.
• Read carefully the “Instructions for use”. Do this every time you receive a new package, as there may be updated information.
• If you or your caregiver have any questions, consult your doctor, nurse, or pharmacist.

If you use more Saphnelo than you should
If you have used more Saphnelo than prescribed, contact your doctor immediately.

If you forget to use Saphnelo

• If you miss a dose of Saphnelo, inject a dose as soon as you remember. Then continue with your weekly dosing schedule based on the new day on which Saphnelo was administered or your regularly scheduled time, provided that at least 3 days have passed between doses.
• If you are unsure when to administer the injection, ask your doctor, nurse, or pharmacist.

If you stop using Saphnelo

• Do not stop using Saphnelo without discussing it with your doctor.
• Your doctor will decide whether you need to discontinue treatment with this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions:
Severe allergic reactions ( anaphylaxis ) are not common (may affect up to 1 in 100 people). Contact a doctor immediately, or go to the nearest emergency room, if you develop any of the following signs of a severe allergic reaction:

• swelling of the face, tongue or mouth
• difficulty breathing
• feeling faint, dizzy or lightheaded (due to a drop in blood pressure).

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

• nose or throat infections
• chest infection ( bronchitis )

Common (may affect up to 1 in 10 people)

• sinus or lung infections
• shingles ( herpes zoster ): a red rash that may cause pain and burning
• allergic reactions ( hypersensitivity )

Not known (frequency cannot be estimated from the available data)

• joint pain ( arthralgia )

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly through 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 Saphnelo

Do not use this medicine after the expiry date stated on the label and the carton following
Exp. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect the medicine from light.
Do not freeze, shake, or expose to heat.
If necessary, an unopened carton may be stored at room temperature (20 °C – 25 °C)
for up to 7 days. After being removed from the refrigerator and reaching room temperature (20 °C – 25 °C),
the Saphnelo pre-filled syringe must be used within 7 days or must be discarded.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Saphnelo contains

• The active substance is anifrolumab. Each pre-filled syringe contains 120 mg of anifrolumab.
• The other components are histidine, monohydrate hydrochloride histidine, lysine hydrochloride, trehalose dihydrate, polysorbate 80 (E 433) (see section 2 “Saphnelo contains polysorbate”) and water for injections.

Description of the appearance of Saphnelo and contents of the pack

• Saphnelo is a solution ranging from clear to opalescent, colourless to yellowish.
• Saphnelo is available in packs containing 1 pre-filled syringe.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600
Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

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.

Instructions for use

Saphnelo 120 mg solution for injection in pre-filled syringe

anifrolumab
These “Instructions for use” contain information on how to administer the injection using the
Saphnelo pre-filled syringe.
Read these “Instructions for use” before starting to use the Saphnelo pre-filled syringe

Saphnelo and each time you receive a new syringe. There may be new information.

This information does not replace discussions with your healthcare provider regarding your medical
condition or treatment.
Your healthcare provider must show you or the person assisting you how to correctly use the
Saphnelo pre-filled syringe. If you or the person assisting you has any questions, consult your
healthcare provider. The Saphnelo pre-filled syringe must only be used under the skin (subcutaneously).

Important information and storage instructions

• Store the Saphnelo pre-filled syringe in the refrigerator at a temperature between 2 °C and 8 °C, inside the original packaging until ready for use. If necessary, an unopened package may be stored at room temperature between 20 °C and 25 °C for up to 7 days.
• Keep the Saphnelo pre-filled syringe in its original packaging to protect it from light.
• Each Saphnelo pre-filled syringe contains a single dose for single use only. Do not share the Saphnelo pre-filled syringe with other people.

Do not use the Saphnelo pre-filled syringe if:

• it has been frozen or exposed to heat;
• it has fallen, is damaged, or appears tampered with. Do not shake the Saphnelo pre-filled syringe. If any of these events occur, dispose of the pre-filled syringe in a puncture-resistant container (for sharp objects) and use a new pre-filled syringe. Keep this medicine out of sight and reach of children.

Components of the Saphnelo pre-filled syringe
Do not remove the needle cap until immediately before administering the Saphnelo injection.
Do not touch the needle guard activation clips. Doing so may cause premature activation of the needle guard.

Before use After use
Expiration date label Observation window Needle guard activation clip Needle guard

Plunger
head
Cap
Barrel Plunger Needle (covered) Plunger
of the
needle syringe
Needle Syringe
flange
Preparing for injection using the Saphnelo pre-filled syringe
Step 1 – Gather injection materials

1 pre-filled syringe of Saphnelo 1 alcohol 1 cotton 1 adhesive 1 sharps
from the refrigerator impregnated pad gauze container for
with alcohol or hydrophilic cotton safe disposal
of sharp objects
Not included
See Step 9 for instructions on how to safely dispose of the used pre-filled Saphnelo syringe.
Step 2 – Check packaging and wait 60 minutes
Choose a flat, clean, well-lit work surface, such as a
table.
Check the expiration date (Exp.) on the packaging.

• Do not use if the expiration date has passed. Check that the packaging is not damaged.
• Do not use if the packaging appears damaged.

Allow the pre-filled Saphnelo syringe to reach room

temperature for 60 minutes before injection.

• Keep the pre-filled Saphnelo syringe in its original packaging for 60 minutes to protect it from light.
• Do not heat the pre-filled Saphnelo syringe by other means. For example, do not heat it in a microwave oven, in warm water, in direct sunlight, or near other heat sources.

Step 3 – Remove the pre-filled syringe from packaging and inspect
Open the package and remove the pre-filled Saphnelo syringe by

holding the middle section of the syringe barrel.

• Do not hold or pull it by the plunger.

Check the expiration date on the pre-filled syringe.

• Do not use if the expiration date has passed.

Inspect the pre-filled syringe for any damage.

• Do not use if it is damaged.

Check the liquid through the viewing window.

• The liquid should be clear, colorless to slightly yellow. Expiration date
• Do not use if the liquid appears cloudy, has changed color, or contains visible particles.
• It is normal to see small air bubbles in the liquid. Do not attempt to remove the air bubbles.

Injection of Saphnelo
Step 4 – Select injection site
You or the person assisting you may administer the injection into the
front of the thigh or lower abdomen (abdominal area).
A person assisting you may also administer the injection into the
upper arm.
Do not self-inject at this site.
Choose a different injection site at least 3 cm away from the previous injection site.
Do not administer the injection:

• in the area within 5 cm around the navel;
• where the skin is red, tender, painful, bruised, scaly, or hardened;
• on scarred, damaged, depigmented, or tattooed skin;
• through clothing.

Step 5 – Wash hands and disinfect injection site
Wash your hands thoroughly with soap and water.
Disinfect the injection site with an alcohol-impregnated wipe or with soap and water. Allow the site to
air dry.

• Do not touch the cleaned injection site again or blow on it before administering the injection.
  Step 6 – Remove the needle cap

Hold the barrel of the pre-filled syringe with one hand and carefully remove the needle cap vertically with the other hand.

• Do not twist or shake the needle cap when removing it.
• Do not touch or pull the plunger or plunger head while removing the needle cap.
• You may notice a drop of liquid at the tip of the needle. This is normal.
• Do not replace the cap on the needle. Set the needle cap aside for disposal later.
• Do not touch the needle and avoid letting it contact any surface.
• Do not use if the needle is damaged or dirty.

Proceed immediately to Step 7 after removing the needle cap.
Step 7 – Injecting Saphnelo
Hold the pre-filled Saphnelo syringe in one hand as shown. Use the other hand to gently pinch and

hold the cleaned injection site between your fingers.

• Do not press the plunger head until the needle is inserted into the skin.
• Never pull back the plunger head. Inject using the pre-filled syringe by following the steps shown in figures a, b, and c.

a b c

45°
Insert the entire needle into the pinched skin at a 45-degree angle. Push the plunger fully to the bottom with your thumb. Release the plunger slowly until the needle safety guard covers the needle. If the needle is not covered, immediately dispose of (discard) the syringe carefully (see Step 9).
Do not reposition the pre-filled syringe after inserting the needle into the skin. To ensure all medication is delivered and the needle safety guard is activated, continue firmly pressing the plunger until it is completely depressed to the bottom.
Step 8 – Check injection site
A small amount of

blood or liquid may be present at the injection site. This is normal.
If needed, press a cotton pad or gauze on the area and apply a small adhesive bandage.

• Do not rub the injection site.

Step 9 – Disposal of the used pre-filled Saphnelo syringe
Each pre-filled syringe contains a single dose of

Saphnelo and must not be reused. Do not recap the needle.
Place the used pre-filled Saphnelo syringe immediately into a
sharps disposal container after use.
Do not dispose of the pre-filled Saphnelo syringe in household waste.
Disposal guidelines
Dispose of the full container according to instructions provided by your healthcare provider or pharmacist.
Do not dispose of the used sharps container in household waste unless permitted by local community guidelines.
Do not recycle the used sharps container.

Patient Information Leaflet

Saphnelo 1 20 mg solution for injection in pre-filled pen

anifrolumab
This medicinal product is subject to additional monitoring. This will allow rapid 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 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, nurse or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
• 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.

Contents of this leaflet

1. What Saphnelo is and what it is used for
2. What you need to know before using Saphnelo
3. How to use Saphnelo
4. Possible side effects
5. How to store Saphnelo
6. Contents of the pack and other information

1. What Saphnelo is and what it is used for

What Saphnelo is
Saphnelo contains the active substance anifrolumab, a “monoclonal antibody” (a type of protein
specialised in binding to a specific target in the body).

What Saphnelo is used for
Saphnelo is used for the treatment of moderate to severe lupus (systemic lupus erythematosus, SLE)
in adults whose disease is not well controlled with standard therapies (“oral corticosteroids”,
“immunosuppressants” and/or “antimalarials”).
You will be given Saphnelo in addition to standard lupus therapy.
Lupus is a disease in which the immune system (the system that fights infections) attacks the body's
cells and tissues. This causes inflammation and organ damage. It can affect almost any organ in the
body, including the skin, joints, kidneys, brain, and other organs. It may cause pain, skin rashes, joint
swelling, fever, and a feeling of extreme tiredness or weakness.

How Saphnelo works
People with lupus have high levels of proteins called “type 1 interferons” that stimulate immune system
activity. Anifrolumab binds to a target (receptor) where these proteins act, thereby interrupting their
function. By blocking their action in this way, it may reduce the inflammation causing lupus symptoms
in your body.

Benefits of using Saphnelo
Saphnelo may help reduce lupus disease activity and decrease the number of flare-ups.
If you are taking medicines called “oral corticosteroids”, using Saphnelo may also allow your doctor to
reduce the daily oral corticosteroid dose needed to help control lupus.

2. What you need to know before using Saphnelo

Do not use Saphnelo

• if you are allergic to anifrolumab or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before using Saphnelo:

• if you think you have ever had an allergic reaction to this medicine (see below “Be aware of signs of allergic reactions and serious infections”).
• if you think you have an infection or if you develop symptoms of an infection (see below under “Be aware of signs of allergic reactions and serious infections”).
• if you have a long-lasting infection or if you have an infection that keeps recurring.
• if lupus affects your kidneys or nervous system.
• if you have or have had cancer.
• if you have recently received a vaccination (vaccine) or plan to receive one. You must not receive certain types of vaccines (‘live’ or ‘attenuated’ vaccines) while being treated with this medicine.
• if you are receiving another biological medicine (such as belimumab for lupus).

If you are not sure whether any of the conditions described above apply to you, talk to your doctor or
nurse before receiving Saphnelo.
Be aware of signs of allergic reactions and serious infections
Saphnelo can cause serious allergic reactions (anaphylaxis), see section 4. Contact your doctor immediately
if you suspect you are having a serious allergic reaction. Signs may include:

• swelling of the face, tongue, or mouth
• difficulty breathing
• feeling faint, dizzy, or lightheaded (due to a drop in blood pressure).

You may be at higher risk of developing an infection while being treated with Saphnelo. Inform your doctor or nurse as soon as possible if you notice signs of any possible infection, including:

• fever or flu-like symptoms
• muscle aches
• cough or shortness of breath (these may be signs of a respiratory infection, see section 4)
• burning sensation when urinating or more frequent urination than usual
• diarrhoea or stomach pain
• a red rash that may be painful and cause burning (this may be a sign of shingles, see section 4).

Each time you receive a new pack of Saphnelo

• Write down the name and batch number shown on the outer carton and on the pre-filled pen label, and keep this information in a safe place. You may need to provide this information in the future.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it has not been studied in patients of this age group.
Other medicines and Saphnelo

• Inform your doctor if you are taking, have recently taken, or might take any other medicines.
• Inform your doctor if you have recently received or are due to receive a vaccination. You must not receive certain types of vaccines while using this medicine. If you are unsure, consult your doctor or nurse before and during treatment with Saphnelo.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
It is not known whether Saphnelo can harm the unborn baby.

• Before starting treatment with Saphnelo, inform your doctor if you are pregnant or think you might be. Your doctor will decide whether this medicine should be given to you.
• Talk to your doctor if you are planning a pregnancy during treatment with this medicine.
• If you become pregnant while being treated with Saphnelo, inform your doctor. Your doctor will discuss with you whether you should stop treatment with this medicine.

Breastfeeding

• If you are breastfeeding, inform your doctor before starting treatment with Saphnelo. It is not known whether this medicine is excreted in breast milk. Your doctor will advise you whether you should stop treatment with this medicine while breastfeeding, or whether you should stop breastfeeding.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery.
Saphnelo contains polysorbate
This medicine contains 0.4 mg of polysorbate 80 (E 433) per pre-filled pen, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Saphnelo

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.
The recommended dose is 120 mg once weekly. Saphnelo is administered as an injection under the skin (subcutaneously).
Your doctor or nurse will decide whether you are able to self-administer the medicine or whether it can be given by the person assisting you.

Before injecting Saphnelo

• Your doctor or nurse must train you or the person assisting you on how to correctly use the Saphnelo pre-filled pen.
• Read the “Instructions for use” carefully. Do this every time you receive a new pack, as there may be new information.
• If you or the person assisting you has any questions, consult your doctor, nurse, or pharmacist.

If you use more Saphnelo than you should
If you have used more Saphnelo than prescribed, consult your doctor immediately.

If you forget to use Saphnelo

• If you miss a dose of Saphnelo, inject a dose as soon as you remember. Then continue with your weekly dosing based on the new day on which Saphnelo was administered or your regularly scheduled time, provided that at least 3 days have passed between doses.
• If you are unsure about when to administer the injection, ask your doctor, nurse, or pharmacist.

If you stop using Saphnelo

• Do not stop using Saphnelo without discussing it with your doctor.
• Your doctor will decide whether you need to discontinue treatment with this medicine.

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

4. Possible side effects

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

Serious allergic reactions:
Serious allergic reactions ( anaphylaxis ) are uncommon (may affect up to 1 in 100 people). Contact a doctor immediately or go to the nearest emergency room if you develop any of the following signs of a serious allergic reaction:

• swelling of the face, tongue or mouth
• difficulty breathing
• feeling faint, dizzy or lightheaded (due to a drop in blood pressure).

Other side effects:
Tell your doctor or nurse if you notice any of the following side effects.

Very common (may affect more than 1 in 10 people)

• nose or throat infections
• chest infection ( bronchitis )

Common (may affect up to 1 in 10 people)

• sinus or lung infections
• shingles ( herpes zoster ): a red rash which may cause pain and burning
• allergic reactions ( hypersensitivity )

Not known (frequency cannot be estimated from the available data)

• joint pain ( arthralgia )

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor 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 Saphnelo

Do not use this medicinal product after the expiry date stated on the label and the carton, following "Exp." The expiry date refers to the last day of that month.
Keep this medicinal product out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Keep in the original packaging to protect the medicinal product from light.
Do not freeze, shake, or expose to heat.
If necessary, the Saphnelo pre-filled pen may be stored at room temperature (20°C – 25°C) for up to 7 days, protected from light. Once the Saphnelo pre-filled pen has reached room temperature (20°C – 25°C), do not return it to the refrigerator. If it has not been used within 7 days of storage at room temperature, it must be discarded.
Do not dispose of any medicinal product via wastewater. 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 Saphnelo contains

• The active substance is anifrolumab. Each pre-filled pen contains 120 mg of anifrolumab.
• The other components are histidine, monohydrate histidine hydrochloride, lysine hydrochloride, trehalose dihydrate, polysorbate 80 (E 433) (see section 2 “Saphnelo contains polysorbate”), and water for injections.

Description of the appearance of Saphnelo and contents of the pack

• Saphnelo is a solution that ranges from clear to opalescent and from colourless to slightly yellow.
• Saphnelo is available in packs containing 1 or 4 pre-filled pens, or in a multiple pack containing 12 pre-filled pens (3 packs of 4).

Not all pack sizes may be marketed.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600
Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

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.

Instructions for use

Saphnelo 120 mg solution for injection in a pre-filled pen

anifrolumab
These “Instructions for Use” contain information on how to administer the injection using the
Saphnelo pre-filled pen.
Read these “Instructions for Use” before starting to use the Saphnelo pre-filled pen

Saphnelo and each time you receive a new pen. There may be new information.

These instructions do not replace a conversation with your healthcare provider regarding your medical
condition or treatment.
Your healthcare provider must show you or the person assisting you how to correctly use the Saphnelo
pre-filled pen. If you or the person assisting you has any questions, consult your healthcare provider. The
Saphnelo pre-filled pen must be used only under the skin (subcutaneously).

Important information and storage warnings

• Store the Saphnelo pre-filled pen in the refrigerator at a temperature between 2 °C and 8 °C in the original packaging to protect it from light. If necessary, the Saphnelo pre-filled pen may be stored at room temperature between 20 °C and 25 °C for up to 7 days protected from light.
• Once the Saphnelo pre-filled pen has reached room temperature, do not return it to the refrigerator. If it is not used within 7 days of storage at room temperature, dispose of it.
• Each Saphnelo pre-filled pen contains 1 dose intended for single use only. Do not share the Saphnelo pre-filled pen with other people. Do not use the Saphnelo pre-filled pen if:
  • it has been frozen or exposed to heat;
  • it has been dropped, damaged, or appears tampered with. Do not shake the Saphnelo pre-filled pen. If any of the above conditions occur, discard the Saphnelo pre-filled pen into a puncture-resistant sharps disposal container and use a new Saphnelo pre-filled pen. Keep this medicine out of sight and reach of children.

Components of the Saphnelo pre-filled pen
Do not remove the cap until immediately before administering the Saphnelo injection.
Do not touch the green needle shield.

Before use After use
Observation window Cap
(removed)
Protective sleeve

Green Needle Shield
Green liquid expiry date
(cap) (needle
inside)
Preparing for injection with the Saphnelo pre-filled pen
Step 1 – Gather injection materials

1 pre-filled pen of Saphnelo 1 alcohol swab 1 cotton ball 1 adhesive bandage 1 sharps
from the refrigerator soaked in hydrophilic pad for safe
alcohol or gauze disposal
Not included
See Step 10 for instructions on how to safely dispose of the used
Saphnelo pre-filled pen.
Step 2 – Remove the Saphnelo pre-filled pen from its packaging and wait 60 minutes
Choose a flat, clean, well-lit surface, such as a table.
Check the expiry date (Exp) on the packaging.

• Do not use if the expiry date has passed. Ensure the packaging is undamaged.
• Do not use if the packaging appears damaged.

Open the packaging and remove one Saphnelo pre-filled pen by gently holding the middle part of the device.

• Store any remaining Saphnelo pre-filled pens in the original packaging and return them to the refrigerator.

Allow the Saphnelo pre-filled pen to reach room temperature for 60 minutes before injection.

• Do not heat the Saphnelo pre-filled pen by other means. For example, do not heat it in a microwave, in warm water, in direct sunlight, or near other heat sources. 60 min

Step 3 – Inspect the Saphnelo pre-filled pen
Check the expiry date on the Saphnelo pre-filled pen.

• Do not use if the expiry date has passed.
  Inspect the Saphnelo pre-filled pen for any damage.
• Do not use if it is damaged.

Check the liquid through the viewing window.

• The liquid should be clear, from colourless to slightly yellow.
• Do not use if the liquid appears cloudy, has changed colour, or contains visible particles.
• It is normal to see small air bubbles in the liquid. Do not attempt to remove the air bubbles.

Injecting Saphnelo
Step 4 – Choose the injection site
You or your caregiver may administer the injection into the front of the thigh or the lower abdomen (abdomen).
A caregiver may also administer the injection into the upper arm.
Do not self-inject into this site.
Choose a different injection site at least 3 cm away from the previous injection site.
Do not inject:

• in the area extending up to 5 cm around the navel;
• where the skin is red, sensitive, painful, bruised, scaly, or hardened;
• into scarred, damaged, lighter-coloured, or tattooed skin;
• through clothing.

Step 5 – Wash hands and disinfect the injection site
Wash your hands thoroughly with soap and water.
Clean the injection site with an alcohol swab or with soap and water. Allow the site to air dry.

• Do not touch the cleaned injection site again or blow on it before administering the injection.

Step 6 – Remove the cap
Do not remove the cap until you are ready to perform the injection.
Pull off the cap. Protective
sleeve

• The Saphnelo pre-filled pen is now unlocked and ready for injection.
• Do not touch the green needle shield or the needle inside.
• Do not re-cap the Saphnelo pre-filled pen. This could cause the medicine to be released too early or damage the pen. Proceed immediately to Step 7 after removing the cap.

Green needle shield
Step 7 – Inject Saphnelo
Inject using the Saphnelo pre-filled pen by following the steps shown in figures a, b, c, and d. a
To administer a full dose, press and hold the Saphnelo pre-filled pen for about 15 seconds until the green plunger fills the viewing window.
You may hear a first “click” at the beginning of the injection and a second “click” at the end of the injection.
Do not move or reposition the pre-filled pen once the injection has started.
Position the Saphnelo pre-filled pen.

• Place the green needle shield flat against the skin (at a 90-degree angle).
• Make sure you can see the viewing window.

c d

b
15
sec
Press firmly and hold Hold firmly for about After completing the
against the skin. 15 seconds. injection, lift the pre-filled
• The green plunger will pen straight up.
fill the viewing window. • The green needle shield
• You may hear the first will slide down over the
“click” immediately. This needle and lock in place.
indicates the injection has started.

Step 8 – Check the viewing window
Check the viewing window to ensure that all the medicine has been injected.

If the green plunger does not fill the viewing window, you may not have received the full dose.

• If this occurs or if you have any concerns, contact your healthcare provider.

Before injection After injection
Step 9 – Check the injection site
A small amount of blood or liquid at the injection site may be present. This is normal.

If needed, press a cotton ball or gauze pad on the area and apply a small adhesive bandage.

• Do not rub the injection site.

Step 10 – Disposal (safe disposal) of the used Saphnelo pre-filled pen

Place the used Saphnelo pre-filled pen immediately into a sharps disposal container after use.
Do not throw away (dispose of) the Saphnelo pre-filled pen in household waste.
Disposal guidelines
Dispose of the full container according to instructions provided by your healthcare provider or pharmacist.
Do not dispose of the used sharps container in household waste unless permitted by local community guidelines.
Do not recycle the used sharps disposal container.