Patient Medication Information: uses, side effects, how to take - Oxlumo
What OXLUMO is used for:
OXLUMO is used to lower oxalate levels in the urine and blood in adults and children with primary hyperoxaluria type 1 (PH1).
How OXLUMO works:
PH1 is an illness where the liver makes too much of a substance called oxalate. Oxalate is removed by the kidneys and is passed out in urine.
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 PH1.
The ingredients in OXLUMO are:
Medicinal ingredients: lumasiran sodium
Non-medicinal ingredients: phosphoric acid, sodium hydroxide, and water for injection
OXLUMO comes in the following dosage form:
Solution for injection: 94.5 mg / 0.5 mL lumasiran (as lumasiran sodium)
Do not use OXLUMO if:
- you are allergic to lumasiran, or any of the other ingredients of this medicine. If you are not sure, talk to your healthcare professional before you are given this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OXLUMO. Talk about any health conditions or problems you may have, including if you:
- have severe kidney problems. Your healthcare professional may monitor you for signs of a build-up of acid in your body (metabolic acidosis).
- are on hemodialysis treatment.
are pregnant or planning on becoming pregnant. It is not known if OXLUMO will harm your unborn child.
- are breast-feeding or planning to breastfeed. You and your healthcare professional should decide if the benefit of breastfeeding is greater than the risk to your baby. This is because this medicine may pass into the breast milk and it is not known how it will affect the baby.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with OXLUMO:
Interactions with other drugs are not known at this time.
How to take OXLUMO:
- OXLUMO will be given to you by a healthcare professional.
- It is given as an injection under the skin. This is called subcutaneous injection. It will be given in your stomach area (abdomen), thigh, or the side or back on your upper arm. The site of injection will rotate.
- You will receive your first doses (loading doses) once a month for 3 months. Your maintenance dosing will start 1 month after the last loading dose.
Usual dose:
Your healthcare professional will determine how much OXLUMO to give you. Your dose will depend on your body weight. Your healthcare professional will adjust your dose as your weight changes.
You will be given your first doses (loading dose) once a month for 3 doses. You will then start maintenance dosing one month after your last loading dose.
| Body Weight | Loading dose First 3 months (for 3 doses) | Maintenance Dose Beginning 1 month after last loading dose (4th dose and onwards) |
|---|---|---|
| Less than 10 kg | 6 mg for every kg you weigh, once a month | 3 mg for every kg you weigh, once a month |
| 10 kg to less than 20 kg | 6 mg for every kg you weigh, once a month | 6 mg for every kg you weigh, once every 3 months |
| 20 kg or more | 3 mg for every kg you weigh, once a month | 3 mg for every kg you weigh, once every 3 months |
Overdose:
| If you think you, or a person you are caring for, have taken too much OXLUMO, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed Dose:
If you have missed an appointment for your injection, talk to your healthcare professional as soon as possible.
Possible side effects from using OXLUMO:
These are not all the possible side effects you may have when taking OXLUMO. If you experience any side effects not listed here, tell your healthcare professional.
- Redness, pain, itching, or swelling at the site of the injection
- Stomach pain or discomfort
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Unknown Frequency | ||
| Hypersensitivity (allergic reaction): rash, itching, throat irritation, watery eyes | ||
| ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store at 2°C to 30°C.
- Keep OXLUMO vial in the original carton to protect from light until ready for use.
- Keep out of reach and sight of children.
- Do not use this medicine after the expiration date, which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
If you want more information about OXLUMO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (https://www.alnylam.ca/), or by calling 1-877-256-9526.