InfoCons Consumer Protection informs you – Oxlumo – Package Leaflet

Before anything else

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 further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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 PH1 is PH1 is a rare illness in which the liver produces too much of a substance called oxalate. Your kidneys remove oxalate from the body and it is passed out in the urine. In people with PH1, the extra oxalate can build up in the kidneys and cause kidney stones , and can stop the kidney from working as well as they should. A build-up of oxalate can also damage other parts of the body such as eyes, heart, skin, and bone. This is called oxalosis.

How Oxlumo works

Lumasiran, the active substance in Oxlumo, reduces the amount of an enzyme called glycolate oxidase that the liver makes. Glycolate oxidase is one of the enzymes involved in producing oxalate. By lowering the amount of the enzyme, the liver produces less oxalate and the levels of oxalate in the urine and blood also fall. This can help to reduce the effects of the illness.

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

You must not be given Oxlumo:

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

25 Warnings and precautions Talk to your doctor before being given this medicine.

Your doctor may monitor you for signs of metabolic acidosis (the build-up of acid in the body) if you have severe renal impairment.

Other medicines and Oxlumo

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, 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 risks to your unborn baby.

Breast-feeding

This medicine may pass into breast milk and it could have an effect on your baby. If you are breast -feeding, ask your doctor for advice before taking this medicine. Your doctor will help you decide whether to stop breast -feeding or to stop treatment.

Driving and using machines

This medicine is unlikely to have any effect on your ability to drive or use machines.

Oxlumo contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium -free’.

💊 3. How Oxlumo is given

How much Oxlumo is given Your doctor will work out how much medicine to give you. The dose will depend on how much you weigh. Your doctor will adjust your dose as your weight changes.

You will receive your first doses (loading doses) once a month for 3 doses. You will then start maintenance dosing beginning one month after the last loading dose.

Body weight less than 10 kg

• Loading doses: 6 mg for every kg of your weight, given once a month for 3 doses.
• Maintenance dosing: 3 mg for every kg of your weight, given once every month beginning one month after the last loading dose .

Body weight from 10 kg to less than 20 kg

• Loading doses: 6 mg for every kg of your weight, given once a month for 3 doses.
• Maintenance dosing: 6 mg for every kg of your weight, given once every 3 months beginning one month after the last loading dose.

Body weight 20 kg or more

• Loading doses: 3 mg for every kg of your weight, given once a month for 3 doses.
• Maintenance dosing: 3 mg for every kg of your weight, given once every 3 months beginning one month after the last loading dose.

How Oxlumo is given This medicine will be given to you by a doctor or nurse.

• It is given as an injection under the skin (subcutaneously) into your stomach area (abdomen), or in some cases, your upper arm or thigh. You will be given the injection in a different spot from one injection to the next.
• Depending on your dose, more than one subcutaneous injection may need to be given.
• Your doctor or nurse will not inject into skin areas that are scarred, reddened, inflamed, or swollen.

If you are given too much Oxlumo In the unlikely event that your doctor or nurse gives you too much (an overdose) they will check you for side effects.

If you miss your dose of Oxlumo If you miss a dose of Oxlumo, talk to your doctor or nurse as soon as possible about when to get your next dose.

If you have any further questions on the use of this medicine, ask 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 when taking Oxlumo:

Very common: may affect more than 1 in 10 people

• Redness, pain, itching, swelling, discomfort, colour changes, mass, induration, rash, bruising or exfoliation at the site of the injection (injection site reaction).
• Stomach 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 watery eyes.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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, which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

This medicine is for single use only. Once the vial is opened, use immediately.

Do not store above 30 °C.

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicines that are no longer being used. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Oxlumo contains

• The active substance is lumasiran.
• Each vial contains lumasiran sodium equivalent to 94.5 mg lumasiran.
• The other ingredients are water for injections, sodium hydroxide (E524), and phosphoric acid

(E338) (see “Oxlumo contains sodium” in section 2).

What Oxlumo looks like and contents of the pack

This medicine is a clear, colourless-to -yellow solution for subcutaneous injection.

Each pack contains one single use vial containing 0.5 mL solution.

Marketing Authorisation Holder and Manufacturer

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Alnylam Netherlands B.V.

Tél/Tel: 0800 81 443 (+32 234 208 71) [email protected] България Genesis Pharma Bulgaria EOOD Teл.: +359 2 969 3227 [email protected] Lietuva Medison Pharma Lithuania UAB Tel: +31 20 369 7861 medinfo.lithuania@m edisonpharma .com Luxembourg/Luxemburg Alnylam Netherlands B.V.

Tél/Tel: 80085235 (+352 203 014 48) [email protected] Česká republika Medison Pharma s.r.o.

Tel: +31 20 369 7861 [email protected] Magyarország Medison Pharma Hungary Kft Tel.: +31 20 369 7861 medinfo.hungary @medisonpharma .com 28 Danmark Alnylam Sweden AB Tlf.: 433 105 15 (+45 787 453 01) [email protected] Malta Genesis Pharma (Cyprus) Ltd Tel: +357 22765715 [email protected] Deutschland Alnylam Germany GmbH Tel: 08002569526 (+49 8920190112) [email protected] Nederland Alnylam Netherlands B.V.

Tel: 08002820025 (+31 203697861) [email protected] Eesti Medison Pharma Estonia OÜ Tel: +31 20 369 7861 [email protected] Norge Alnylam Sweden AB Tlf: 800 544 00 (+472 1405 657) [email protected] Ελλάδα ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε Τηλ: +30 210 87 71 500 [email protected] Österreich Alnylam Austria GmbH Tel: 0800070339 (+43 720 778 072) [email protected] España Alnylam Pharmaceuticals Spain SL Tel: 900810212 (+34 910603753) [email protected] Polska Medison Pharma Sp. z o.o.

Tel.: +31 20 369 7861 [email protected] France Alnylam France SAS Tél: 0805542656 (+33 187650921) [email protected] Portugal Alnylam Portugal Tel: 707201512 (+351 21 269 8539) [email protected] Hrvatska Genesis Pharma Adriatic d.o.o Tel: +385 1 5530 011 [email protected] România Genesis Biopharma Romania SRL Tel: +40 21 403 4074 [email protected] Ireland Alnylam Netherlands B.V.

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

Sími: +31 20 369 7861 [email protected] Slovenská republika Medison Pharma s.r.o.

Tel: +31 20 369 7861 medinfo. slovakia @medisonpharma .com Italia Alnylam Italy S.r.l.

Tel: 800 90 25 37 (+39 02 89 73 22 91) [email protected] Suomi/Finland Alnylam Sweden AB Puh/Tel: 0800 417 452 (+358 942 727 020) [email protected] Κύπρος Genesis Pharma (Cyprus) Ltd Τηλ: +357 22765715 [email protected] Sverige Alnylam Sweden AB Tel: 020109162 (+46 842002641) [email protected] 29 Latvija Medison Pharma Latvia SIA Tel: +31 20 369 7861 medinfo.l atvia @medisonpharma .com This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu ————————————————————————————————————————

🩺 Information intended for healthcare professionals only

Instructions for use For subcutaneous use only.

• Collect materials not included in the pack that are needed for administration which will include 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 weight -based dose. If the dose is more than 0.5 mL, you will need to use more than one vial. The maximum acceptable single injection volume to be administered is 1.5 mL. If more than 1.5 mL is needed, you may need to give more than one subcutaneous injection.
• Use a 18 G needle to withdraw Oxlumo from the vial , hold the vial upright or tilt at a slight angle and ensure the flat edge of the needle is pointed downwards.
• Point the needle and syringe straight up and tap the syringe to move any bubbles to the top. Once the bubbles are at the top, gently push the plunger to force the bubbles out of the syringe. Check to ensure the correct amount of medicine is in the syringe.
• Administer the medicine with a sterile 25 G to 31 G needle with a 13 -mm or 16 -mm needle length for subcutaneous injection. For volumes less than 0.3 mL, a sterile 0.3 -mL syringe is recommended.
• Note: Do not push this medicine into the 25 G to 31 G needle. When using 0.3 mL (insulin) syringes, do not force the bubble from syringe.
• Injection can be into the abdomen, upper arms, or thighs. Consider rotating injection sites. Do not administer into scar tissue or areas that are reddened, inflamed, or swollen.
• Note: When administering subcutaneous injections into the abdomen, avoid a 2-cm diameter circle around the navel.
• Clean the area of planned injection with an alcohol swab and wait for the area to dry completely.
• Ensure proper injection technique. Do not inject into a vein or muscle.
• Insert the needle at a right angle (90 degrees) to deliver the injection just below the skin. In patients with little subcutaneous tissue, the needle should be inserted at a 45 -degree angle.
• Do not press down on the plunger while piercing the skin. Once the needle is inserted through the skin, release the pinched skin and administer the dose in a slow and steady manner. Once the medicine has been administered count for at least 5 seconds befor e withdrawing the needle from the skin. Lightly press gauze or cotton ball on the injection site as needed. Do not put the needle cap back on.
• Note: Do not aspirate after inserting the needle to prevent tissue damage, haematoma, and bruising.
• If more than one injection is needed for a single dose of Oxlumo, the injection sites should be at least 2 cm apart.
• Only use the vial once. After administering the dose, dispose of any unused medicine in the vial according to local regulations.

30 • Use the syringes, transfer needles, and injection needles only once. Dispose of any used syringes and needles in accordance with local regulations.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Oxlumo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1496).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.