OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION
Ask a doctor about a prescription for OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION
How to use OXLUMO 94.5 mg/0.5 ml INJECTABLE SOLUTION
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:
- What is Oxlumo and what is it used for
- What you need to know before you use Oxlumo
- How to use Oxlumo
- Possible side effects
- Storage of Oxlumo
- 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.
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.
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) Genesis Pharma Bulgaria EOOD Тел: +359 2 969 3227 | Luxembourg/Luxemburg Alnylam Netherlands B.V. Tél/Tel: 80085235 (+352 203 014 48) Lietuva Medison Pharma Lithuania UAB Tel: +31 20 369 7861 |
Ceská republika Medison Pharma s.r.o. Tel: +31 20 369 7861 | Magyarország Medison Pharma Hungary Kft Tel: +31 20 369 7861 Malta Genesis Pharma (Cyprus) Ltd Tel: +357 22765715 |
Nederland Alnylam Netherlands B.V. Tel: 08002820025 (+31 203697861) | |
Danmark Alnylam Sweden AB Tlf: 433 105 15 (+45 787 453 01) | Norge Alnylam Sweden AB Tlf: 800 544 00 (+472 1405 657) |
Deutschland Alnylam Germany GmbH Tel: 08002569526 (+49 8920190112) Eesti Medison Pharma Estonia OÜ Tel: +31 20 369 7861 medinfo.estonia@medisonpharma | Österreich Alnylam Austria GmbH Tel: 0800070339 (+43 720 778 072) Polska Medison Pharma Sp. z o.o. Tel: +31 20 369 7861 |
Ελλάδα ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε Τηλ: +30 210 87 71 500 | Portugal Alnylam Portugal Tel: 707201512 (+351 21 269 8539) |
España Alnylam Pharmaceuticals Spain SL Tel: 900810212 (+34 910603753) | România Genesis Biopharma Romania SRL Tel: +40 21 403 4074 |
France Alnylam France SAS Tél: 0805542656 (+33 187650921) Hrvatska Genesis Pharma Adriatic d.o.o Tel: +385 1 5530 011 | Slovenija Genesis Pharma Biopharma SL d.o.o Tel: +386 1 292 70 90 Slovenská republika Medison Pharma s.r.o. Tel: +31 20 369 7861 |
Suomi/Finland Alnylam Sweden AB Puh/Tel: 0800 417 452 (+358 942 727 020) | |
Ireland Alnylam Netherlands B.V. Tel: 1800 924260 (+353 818 882213) Ísland Alnylam Netherlands B.V. Sími: +31 20 369 7861 | Sverige Alnylam Sweden AB Tel: 020109162 (+46 842002641) |
Italia Alnylam Italy S.r.l. Tel: 800 90 25 37 (+39 02 89 73 22 91) | |
Κύπρος Genesis Pharma (Cyprus) Ltd Τηλ: +357 22765715 Latvija Medison Pharma Latvia SIA Tel: +31 20 369 7861 |
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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