Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Oxlumo 94.5 mg/0.5 mL solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lumasiran sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
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). Warnings and precautions Talk to your doctor or nurse before you are 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.
1
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 'sodiumfree'.
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 to take it
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.
2
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
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. 3
•
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: United Kingdom Alnylam UK Ltd. Tel: 0800 141 2569 (+44 1628 878 592) [email protected]
This leaflet was last revised in 06 November 2025.
<————————————————————————————————————————> The following information is 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. 4
• •
• • • •
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 before 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. Use the syringes, transfer needles, and injection needles only once. Dispose of any used syringes and needles in accordance with local regulations.
5
Frequently asked questions about Oxlumo 94.5 mg/0.5 mL solution for injection
How do I take Oxlumo 94.5 mg/0.5 mL solution for injection?
Oxlumo 94.5 mg/0.5 mL solution for injection comes as injection containing 94.5mg / 0.5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Oxlumo 94.5 mg/0.5 mL solution for injection?
The active substance in Oxlumo 94.5 mg/0.5 mL solution for injection is lumasiran sodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Oxlumo 94.5 mg/0.5 mL solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Oxlumo 94.5 mg/0.5 mL solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lumasiran sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
4.2. Posology and method of administration
Therapy should be initiated and supervised by a physician experienced in the management of hyperoxaluria.
Posology
Oxlumo is administered by subcutaneous injection. The recommended dose of Oxlumo consists of loading doses given once a month for 3 doses, followed by maintenance doses beginning one month after the last loading dose, as shown in Table 1. Dosing is based on body weight.
The patient dose (in mg) and volume (in mL) should be calculated as follows:
Patient body weight (kg)×dose (mg/kg)=total amount (mg) of medicinal product to be administered.
Total amount (mg) divided by concentration (189 mg/mL)=total volume of medicinal product (mL) to be injected.
Table 1: Oxlumo weight‑based dosing regimen
Body weight
Loading dose
Maintenance dose (beginning one month after the last loading dose)
less than 10 kg
6 mg/kg once monthly for 3 doses
3 mg/kg once monthly beginning one month after the last loading dose
10 kg to less than 20 kg
6 mg/kg once monthly for 3 doses
6 mg/kg once every 3 months (quarterly) beginning one month after the last loading dose
20 kg and above
3 mg/kg once monthly for 3 doses
3 mg/kg once every 3 months (quarterly) beginning one month after the last loading dose
Patients on haemodialysis
Administer Oxlumo following haemodialysis if administered on dialysis days.
Missed dose
If a dose is delayed or missed, treatment should be administered as soon as possible. Prescribed monthly or quarterly dosing should be resumed from the most recently administered dose.
Special populations
Elderly
No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Hepatic impairment
Oxlumo has not been studied in patients with hepatic impairment. No dose adjustment is necessary in patients with transient elevation in total bilirubin (total bilirubin >1 to 1.5×ULN). Caution is required when treating patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Renal impairment
No dose adjustment is necessary in patients with renal impairment estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2) including end-stage renal disease (ESRD), or those on dialysis. Limited data are available in patients with ESRD and on dialysis, and these patients should be treated with caution (see sections 4.4 and 5.2).
Paediatric population
In patients under 1 year of age, limited data are available. Caution should be used when treating these patients (see section 5.2).
Method of administration
For subcutaneous use only.
This medicinal product is provided as a ready-to-use solution in a single-use vial.
• The required volume of Oxlumo should be calculated based on the recommended weight‑based dose as shown in Table 1.
• If the dose is more than 0.5 mL (94.5 mg), more than one vial will be needed.
• The maximum acceptable single injection volume is 1.5 mL. Doses requiring more than 1.5 mL should be administered as multiple injections (the total dose divided equally between syringes with each injection containing approximately the same volume) to minimise potential injection site discomfort due to injection volume.
• Having the medicinal product on the needle tip before the needle is in the subcutaneous space should be avoided.
• This medicinal product should be injected subcutaneously into the abdomen, upper arms, or thighs.
• For subsequent injections or doses, rotating the injection site is recommended.
• This medicinal product should not be administered into scar tissue or areas that are reddened, inflamed, or swollen.
Oxlumo should be administered by a healthcare professional. For instructions on preparation of the medicinal product before administration see section 6.6. For instructions for use, see the information intended for healthcare professionals only, at the end of the package leaflet.
4.3. Contraindications
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Severe or end-stage renal impairment
Treatment with lumasiran increases plasma glycolate levels, which may increase the risk of metabolic acidosis or worsening of pre-existing metabolic acidosis in patients with severe or end‑stage renal disease. These patients should therefore be monitored for signs and symptoms of metabolic acidosis.
Moderate or severe hepatic impairment
In patients with moderate or severe hepatic impairment there is a potential for decreased efficacy. Therefore, efficacy should be monitored in these patients (see section 5.2).
Excipient with known effect
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodium‑free'.
4.5. Interaction with other medicinal products and other forms of interaction
No clinical drug interaction studies have been performed (see section 5.2).
Concomitant use with pyridoxine
Concomitant use of pyridoxine did not meaningfully influence the pharmacodynamics or pharmacokinetics of lumasiran.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of lumasiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). The use of Oxlumo may be considered during pregnancy taking into account the expected health benefit for the woman and potential risks to the foetus.
Breast-feeding
It is unknown whether lumasiran/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast‑feeding or to discontinue/abstain from Oxlumo therapy, taking into account the benefit of breast‑feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effects of lumasiran on human fertility. No impact on male or female fertility was detected in animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Oxlumo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were injection site reaction (35%) and abdominal pain (16%).
Tabulated list of adverse reactions
Adverse reactions associated with lumasiran obtained from clinical studies and spontaneous reporting are tabulated below. The adverse reactions are coded to preferred terms (PTs) under the MedDRA system organ class (SOC) and are presented by frequency. The frequency of the adverse reactions is expressed according to the following categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).
Table 2: Adverse reactions
System organ class
Adverse reaction
Frequency
Immune system disorders
Hypersensitivitya
Not Known
Gastrointestinal disorders
Abdominal painb
Very common
General disorders and administration site conditions
Injection site reactionc
Very common
a Adverse reaction reported during post-marketing use.
b Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, and abdominal tenderness.
c Includes injection site reaction, injection site erythema, injection site pain, injection site pruritus, injection site swelling, injection site discomfort, injection site discolouration, injection site mass, injection site induration, injection site rash, injection site bruising, injection site haematoma and injection site exfoliation.
Description of selected adverse reactions
Injection site reactions
In placebo‑controlled and open‑label clinical studies, injection site reactions were reported in 34 out of 98 patients (34.7%). The most commonly reported symptoms were erythema, swelling, pain, haematoma, pruritus, and discolouration. The majority of injection site reactions started on the day of administration, with < 2% of injection site reactions occurring 5 or more days after administration. Injection site reactions were generally mild, resolved within two days, and did not result in interruption or discontinuation of treatment.
Abdominal pain
In the placebo‑controlled study, abdominal pain was reported in 1 of 13 (7.7%) placebo‑treated patients and 4 of 26 (15.4%) lumasiran‑treated patients. In the placebo‑controlled and open‑label clinical studies, 16 of 98 patients (16.3%) reported abdominal pain, including upper or lower abdominal pain, abdominal discomfort, or abdominal tenderness. Most of the events have been mild, transient, and resolved without treatment. None have resulted in discontinuation of treatment.
Long-term safety
The safety profile of lumasiran in the open-label extension periods of ILLUMINATE-A and ILLUMINATE-B (median treatment duration of 55.0 months and 55.5 months, respectively) was consistent with the known safety profile of lumasiran
Paediatric population
The safety profile of lumasiran was similar in paediatric (aged 4 months to 17 years) and adult patients with PH1.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In case of overdose, it is recommended that the patient be monitored as medically indicated for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- OXLUMO 94,5 mg/0,5 ml prescriptionLUMASIRANUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- OxlumoLumasiranum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Oxlumo 94.5 mg/0.5 mL solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.