Oxlumo

Package leaflet: Information for the patient

Oxlumo 94.5 mg/0.5 mL solution for injection

lumasiran
Please read all of this leaflet carefully before you are given 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 get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Oxlumo is and what it is used for

What Oxlumo is
Oxlumo contains the active substance lumasiran.
What Oxlumo is used for
Oxlumo is used to treat primary hyperoxaluria type 1 (PH1) in adults and children of all ages.
What is PH1
PH1 is a rare disease in which the liver produces an excessive amount of a substance called oxalate. The kidneys remove oxalate from the body through urine. In people with PH1, excess oxalate can accumulate in the kidneys and cause kidney stones, preventing the kidneys from functioning properly. In addition, oxalate buildup can damage other parts of the body such as the eyes, heart, skin, and bones. This condition is known as oxalosis.
How Oxlumo works
Lumasiran, the active substance in Oxlumo, reduces the amount of an enzyme called glycolate oxidase produced by the liver. Glycolate oxidase is one of the enzymes involved in the production of oxalate. By reducing the amount of this enzyme, the liver produces less oxalate, and oxalate levels in the urine and blood decrease. This mechanism may help reduce the effects of the disease.

2. What you need to know before you are given Oxlumo

Do not receive Oxlumo

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

Warnings and precautions
Talk to your doctor before you are given this medicine.
If you have severe renal impairment, your doctor may monitor you to rule out signs of metabolic acidosis (build-up of acid in the body).

Other medicines and Oxlumo
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or nurse for advice before taking this medicine. Your doctor will decide whether you should take Oxlumo after considering the expected health benefits for you, as well as the potential risks for the unborn child.

Breast-feeding
This medicine may pass into breast milk and could have effects on the breast-fed infant. If you are breast-feeding, consult your doctor before taking this medicine. Your doctor will help you decide whether to stop breast-feeding or to stop the treatment.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.

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

3. How Oxlumo is administered

How much Oxlumo will be administered
Your doctor will determine the amount of medicine you will receive. The dose will depend on your body weight. Your doctor will adjust the dose according to any changes in weight.
You will receive the first doses (loading doses) once a month for 3 doses. Afterwards, you will start the maintenance dosing, beginning one month after the last loading dose.

Body weight below 10 kg

• Loading doses: 6 mg per kg of body weight, administered once a month for 3 doses.
• Maintenance dose: 3 mg per kg of body weight, administered once a month starting one month after the last loading dose.

Body weight between 10 kg and less than 20 kg

• Loading doses: 6 mg per kg of body weight, administered once a month for 3 doses.
• Maintenance dose: 6 mg per kg of body weight, administered once every 3 months starting one month after the last loading dose.

Body weight 20 kg and above

• Loading doses: 3 mg per kg of body weight, administered once a month for 3 doses.
• Maintenance dose: 3 mg per kg of body weight, administered once every 3 months starting one month after the last loading dose.

How Oxlumo is administered
This medicine will be administered to you by your doctor or nurse.

• It is given as an injection under the skin (subcutaneous) in the abdominal area (stomach), or in some cases, in the upper arm or thigh. Each injection will be given at a different site.
• Depending on the dose, more than one subcutaneous injection may be required.
• Your doctor or nurse will not administer the injection into areas of skin that are scarred, red, inflamed, or swollen.

If you are given more Oxlumo than you should
In the unlikely event that your doctor or nurse administers more than the prescribed amount (overdose), you will be monitored to check for any occurrence of adverse effects.
If you miss a dose of Oxlumo
If you miss a dose of Oxlumo, contact your doctor or nurse as soon as possible to schedule the next dose.
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 everybody gets them.
The following side effects may occur during treatment with Oxlumo.

Very common: may affect more than 1 in 10 people

• Flushing, pain, itching, swelling, discomfort, colour changes, lump, hardening, rash, bruising, or peeling at the injection site (injection site reaction).
• Abdominal pain or discomfort (abdominal pain).

Not known: frequency cannot be estimated from the available data

• A type of allergic reaction (hypersensitivity), with symptoms such as rash, throat irritation, and tearing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Oxlumo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine is for single use only. Once the vial has been opened, it must be
used immediately.
Do not store above 30°C.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine 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 Oxlumo contains

• The active substance is lumasiran.
• Each vial contains sodium lumasiran equivalent to 94.5 mg of lumasiran.
• The other components are water for injections, sodium hydroxide (E524), and phosphoric acid (E338) (see “Oxlumo contains sodium” in section 2).

Description of the appearance of Oxlumo and contents of the pack
This medicine is a clear, colourless to yellow solution for subcutaneous injection.
Each pack contains a single-use vial containing 0.5 mL of solution.

Marketing Authorisation Holder and Manufacturer
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

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

België/Belgique/Belgien Lietuva
Alnylam Netherlands B.V. Medison Pharma Lithuania UAB
Tél/Tel: 0800 81 443 (+32 234 208 71) Tel: +31 20 369 7861
[email protected] [email protected]

България Luxembourg/Luxemburg
Genesis Pharma Bulgaria EOOD Alnylam Netherlands B.V.
Teл.: +359 2 969 3227 Tél/Tel: 80085235 (+352 203 014 48)
[email protected] [email protected]

Česká republika Magyarország
Medison Pharma s.r.o. Medison Pharma Hungary Kft
Tel: +31 20 369 7861 Tel.: +31 20 369 7861
[email protected] [email protected]

Danmark Malta
Alnylam Sweden AB Genesis Pharma (Cyprus) Ltd
Tlf.: 433 105 15 (+45 787 453 01) Tel: +357 22765715
[email protected] [email protected]

Deutschland Nederland
Alnylam Germany GmbH Alnylam Netherlands B.V.
Tel: 08002569526 (+49 8920190112) Tel: 08002820025 (+31 203697861)
[email protected] [email protected]

Eesti Norge
Medison Pharma Estonia OÜ Alnylam Sweden AB
Tel: +31 20 369 7861 Tlf: 800 544 00 (+472 1405 657)
[email protected] [email protected]

Ελλάδα Österreich
ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε Alnylam Austria GmbH
Τηλ: +30 210 87 71 500 Tel: 0800070339 (+43 720 778 072)
[email protected] [email protected]

España Polska
Alnylam Pharmaceuticals Spain SL Medison Pharma Sp. z o.o.
Tel: 900810212 (+34 910603753) Tel.: +31 20 369 7861
[email protected] [email protected]

France Portugal
Alnylam France SAS Alnylam Portugal
Tél: 0805542656 (+33 187650921) Tel: 707201512 (+351 21 269 8539)
[email protected] [email protected]

Hrvatska România
Genesis Pharma Adriatic d.o.o Genesis Biopharma Romania SRL
Tel: +385 1 5530 011 Tel: +40 21 403 4074
[email protected] [email protected]

Ireland Slovenija
Alnylam Netherlands B.V. Genesis Biopharma SL d.o.o
Tel: 1800 924260 (+353 818 882213) Tel: +386 1 292 70 90
[email protected] [email protected]

Ísland Slovenská republika
Alnylam Netherlands B.V. Medison Pharma s.r.o.
Sími: +31 20 369 7861 Tel: +31 20 369 7861
[email protected] [email protected]

Italia Suomi/Finland
Alnylam Italy S.r.l. Alnylam Sweden AB
Tel: 800 90 25 37 (+39 02 89 73 22 91) Puh/Tel: 0800 417 452 (+358 942 727 020)
[email protected] [email protected]

Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Alnylam Sweden AB
Τηλ: +357 22765715 Tel: 020109162 (+46 842002641)
[email protected] [email protected]

Latvija
Medison Pharma Latvia SIA
Tel: +31 20 369 7861
[email protected]

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

The following information is intended for healthcare professionals only:

Instructions for use
For subcutaneous use only.

• Prepare the materials not included in the package required for administration, namely a sterile syringe (0.3 mL, 1 mL or 3 mL), an 18 gauge (G) needle, and a 25 G to 31 G needle.
• Calculate the required volume of Oxlumo based on the recommended dose according to body weight. If the dose exceeds 0.5 mL, more than one vial will be needed. The maximum acceptable volume for a single injection is 1.5 mL. If more than 1.5 mL is required, administration of more than one subcutaneous injection may be necessary.
• Use an 18 G needle to withdraw Oxlumo from the vial; hold the vial upright or slightly tilted, ensuring the flat tip of the needle is facing downward.
• Point the needle and syringe upward and tap the syringe gently to allow any air bubbles to rise. Then, gently push the plunger to expel the air bubbles from the syringe. Confirm that the syringe contains the correct amount of medication.
• Administer the medication using a sterile 25 G to 31 G needle with a length of 13 mm or 16 mm for subcutaneous injection. For volumes less than 0.3 mL, use of a sterile 0.3 mL syringe is recommended.
• Note: do not push medication into the 25 G to 31 G needle. When using a 0.3 mL syringe (insulin syringe), do not force the expulsion of air bubbles from the syringe.
• The injection can be administered in the abdomen, upper arms, or thighs. Rotate injection sites. Do not administer the medication into scar tissue or in areas that are red, inflamed, or swollen.
• Note: when administering a subcutaneous injection in the abdomen, avoid an area with a diameter of 2 cm around the umbilicus.
• Clean the injection site with an alcohol swab and wait for it to dry completely.
• Ensure correct injection technique is used. Do not inject intravenously or intramuscularly.
• Insert the needle at a 90-degree angle to deliver the solution just beneath the skin. In patients with minimal subcutaneous tissue, insert the needle at a 45-degree angle.
• Do not press the plunger while penetrating the skin. Once the needle is inserted into the skin, release the pinched skin and administer the dose slowly and steadily. After administering the medication, wait at least 5 seconds before removing the needle from the skin. Gently press gauze or a cotton ball over the injection site if needed. Do not recap the needle.
• Note: do not aspirate after needle insertion to avoid tissue damage, hematoma, and bruising.
• If more than one injection is required for a single dose of Oxlumo, injection sites should be at least 2 cm apart from each other.
• Use each vial only once. After administering the dose, dispose of any unused medication in the vial according to local regulations.
• Use syringes, transfer needles, and injection needles only once. Dispose of used syringes and needles according to local regulations.