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OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION

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About the medicine

How to use OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Oxlumo 94.5mg/0.5ml solution for injection

lumasiran

This medicine is subject to additional monitoring, which will help to quickly identify new safety information. You can contribute by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start receiving 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 experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Oxlumo and what is it used for

What is Oxlumo

Oxlumo contains the active substance lumasiran.

What is Oxlumo 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 too much of a substance called oxalate. Your kidneys remove oxalate from your body and pass it into the urine. In people with PH1, excess oxalate can build up in the kidneys and cause kidney stones, as well as stop the kidneys from working normally. Excess oxalate can also damage other parts of the body, such as the eyes, heart, skin, and bones. This is called 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 also decrease. This can help reduce the effects of the disease.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Oxlumo

Oxlumo must not be given to you:

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

Warnings and precautions

Talk to your doctor before you start receiving this medicine.

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

Other medicines and Oxlumo

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or nurse for advice before using this medicine. Your doctor will decide whether you should use Oxlumo after considering the benefits of treatment and the potential risks to your unborn baby.

Breastfeeding

This medicine may pass into breast milk and affect your baby. If you are breastfeeding, ask your doctor for advice before using this medicine. Your doctor will help you decide whether to stop breastfeeding or stop the treatment.

Driving and using machines

Oxlumo is unlikely to affect your ability to drive or use machines.

Oxlumo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml, which is essentially "sodium-free".

3. How to use Oxlumo

How much Oxlumo is given

Your doctor will calculate the amount of medicine to be given to you. The dose will depend on your body weight. Your doctor will adjust the dose according to changes in your weight.

You will receive your first doses (loading doses) once a month for 3 doses. After that, you will start receiving the maintenance dose, starting one month after receiving the last loading dose.

Body weight less than 10 kg

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

Body weight from 10 kg to less than 20 kg

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

Body weight 20 kg or more

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

How Oxlumo is given

The medicine will be given to you by a doctor or nurse.

  • The medicine is given as an injection under the skin (subcutaneously) in the stomach area (abdomen) or, in some cases, in the upper arm or thigh. The injection will be given in a different place each time.
  • Depending on your dose, you may need to receive more than one subcutaneous injection.
  • Your doctor or nurse will not inject the medicine into areas of skin that are scarred, red, inflamed, or swollen.

If you use more Oxlumo than you should

In the unlikely event that your doctor or nurse gives you too much medicine (an overdose), they will monitor you for side effects.

If you miss a dose of Oxlumo

If you miss a dose of Oxlumo, talk to your doctor or nurse as soon as possible to arrange for the next dose.

If you have any other questions about using this medicine, ask your doctor or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 you are given Oxlumo:

Very common:may affect more than 1 in 10 people

  • Redness, pain, itching, swelling, discomfort, color changes, mass, induration, rash, bruising, or exfoliation at the injection site (injection site reaction).
  • Stomach pain or discomfort (abdominal pain)

Frequency not known: 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 experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 the month shown.

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

Do not store above 30°C.

Keep the vial in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

What Oxlumo contains

  • The active substance is lumasiran.
  • Each 0.5 ml vial contains lumasiran sodium equivalent to 94.5 mg of lumasiran.
  • The other ingredients (excipients) are water for injections, sodium hydroxide, and phosphoric acid (see "Oxlumo contains sodium" in section 2).

Appearance and packaging

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

Each pack contains one single-use vial, which contains 0.5 ml of solution.

Marketing authorisation holder and manufacturer

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

You can ask for more information about this medicine from 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]

Genesis Pharma Bulgaria EOOD

Тел: +359 2 969 3227

[email protected]

Luxembourg/Luxemburg

Alnylam Netherlands B.V.

Tél/Tel: 80085235 (+352 203 014 48)

[email protected]

Lietuva

Medison Pharma Lithuania UAB

Tel: +31 20 369 7861

[email protected]

Ceská republika

Medison Pharma s.r.o.

Tel: +31 20 369 7861

[email protected]

Magyarország

Medison Pharma Hungary Kft

Tel: +31 20 369 7861

[email protected]

Malta

Genesis Pharma (Cyprus) Ltd

Tel: +357 22765715

[email protected]

Nederland

Alnylam Netherlands B.V.

Tel: 08002820025 (+31 203697861)

[email protected]

Danmark

Alnylam Sweden AB

Tlf: 433 105 15 (+45 787 453 01)

[email protected]

Norge

Alnylam Sweden AB

Tlf: 800 544 00 (+472 1405 657)

[email protected]

Deutschland

Alnylam Germany GmbH

Tel: 08002569526 (+49 8920190112)

[email protected]

Eesti

Medison Pharma Estonia OÜ

Tel: +31 20 369 7861

medinfo.estonia@medisonpharma

Österreich

Alnylam Austria GmbH

Tel: 0800070339 (+43 720 778 072)

[email protected]

Polska

Medison Pharma Sp. z o.o.

Tel: +31 20 369 7861

[email protected]

Ελλάδα

ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε

Τηλ: +30 210 87 71 500

[email protected]

Portugal

Alnylam Portugal

Tel: 707201512 (+351 21 269 8539)

[email protected]

España

Alnylam Pharmaceuticals Spain SL

Tel: 900810212 (+34 910603753)

[email protected]

România

Genesis Biopharma Romania SRL

Tel: +40 21 403 4074

[email protected]

France

Alnylam France SAS

Tél: 0805542656 (+33 187650921)

[email protected]

Hrvatska

Genesis Pharma Adriatic d.o.o

Tel: +385 1 5530 011

[email protected]

Slovenija

Genesis Pharma Biopharma SL d.o.o

Tel: +386 1 292 70 90

[email protected]

Slovenská republika

Medison Pharma s.r.o.

Tel: +31 20 369 7861

[email protected]

Suomi/Finland

Alnylam Sweden AB

Puh/Tel: 0800 417 452 (+358 942 727 020)

[email protected]

Ireland

Alnylam Netherlands B.V.

Tel: 1800 924260 (+353 818 882213)

[email protected]

Ísland

Alnylam Netherlands B.V.

Sími: +31 20 369 7861

[email protected]

Sverige

Alnylam Sweden AB

Tel: 020109162 (+46 842002641)

[email protected]

Italia

Alnylam Italy S.r.l.

Tel: 800 90 25 37 (+39 02 89 73 22 91)

[email protected]

Κύπρος

Genesis Pharma (Cyprus) Ltd

Τηλ: +357 22765715

[email protected]

Latvija

Medison Pharma Latvia SIA

Tel: +31 20 369 7861

[email protected]

Date of last revision of this leaflet:11/2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu,

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This information is intended only for healthcare professionals:

Instructions for use

For subcutaneous administration only.

  • Gather the materials that are not included in the pack but are necessary for administration, which will include a sterile syringe (0.3 mL, 1 mL, or 3 mL), an 18-gauge needle, and a 25- to 31-gauge needle.
  • Calculate the required volume of Oxlumo based on the recommended dose according to body weight. If the dose is more than 0.5 mL, you will need more than one vial. The maximum acceptable volume of a single injection to be administered is 1.5 mL. If more than 1.5 mL is required, you may need to administer more than one subcutaneous injection.
  • To withdraw Oxlumo, hold the vial upright or at a slight angle and ensure that the flat end of the needle is pointing down.
  • Hold the needle and syringe vertically and gently tap the syringe to bring any air bubbles to the top. Once the bubbles are at the top, gently press the plunger to push the bubbles out of the syringe. Check that the required amount of medicine is in the syringe.
  • Administer the medicine with a sterile 25- to 31-gauge needle, with a length of 13 mm or 16 mm for subcutaneous injection. For volumes less than 0.3 mL, a 0.3 mL sterile syringe is recommended.
  • Note: Do not push the medicine through the 25- to 31-gauge needle. When using 0.3 mL syringes (for insulin), do not push the bubbles out of the syringe.
  • The injection can be given in the abdomen, upper arm, or thigh. Consider alternating injection sites. Do not administer in scarred tissue or areas that are red, inflamed, or swollen.
  • Note: When administering subcutaneous injections in the abdomen, avoid a circular area of 2.0 cm around the navel.
  • Clean the injection site with an alcohol swab and wait for it to dry completely.
  • Use an appropriate injection technique. Do not inject into a vein or muscle.
  • Insert the needle into the skin at the correct angle (90 degrees) to deliver the injection just under the skin. In patients with little subcutaneous tissue, insert the needle at a 45-degree angle.
  • Do not press the plunger while the needle is being inserted through the skin. Once the needle is inserted, release the pinched skin and administer the dose slowly and steadily. After administering the medicine, count to at least 5 seconds before withdrawing the needle from the skin. Gently press a cotton ball or swab over the injection site as needed. Do not replace the needle cap.
  • Note: Do not aspirate after inserting the needle to prevent tissue damage, hematoma, and bruising.
  • If you need to administer more than one injection for a single dose of Oxlumo, the injection sites should be at least 2 cm apart.
  • Use the vial only once. After administering the dose, discard any unused medicine in the vial according to local regulations.
  • Use the syringes, transfer needles, and injection needles only once. Discard all used syringes and needles according to local regulations.

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Frequently Asked Questions

Is a prescription required for OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION?
OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION?
The active ingredient in OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION is lumasiran. This information helps identify medicines with the same composition but different brand names.
Who manufactures OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION?
OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION is manufactured by Alnylam Netherlands B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION?
Other medicines with the same active substance (lumasiran) include AMMONAPS 500 mg TABLETS, AMMONAPS 940 mg/g GRANULES, CERDELGA 84 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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