Oxlumo 94,5 mg/0,5 ml solucion inyectable

Prospect: Information for the Patient

Oxlumo 94.5mg/0.5ml injectable solution

lumasiran

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before you receive this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

What is Oxlumo

Oxlumo contains the active ingredient lumasiran.

How is Oxlumo used

Oxlumo is used for the treatment of 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 an excess of a substance called oxalate. The kidneys eliminate oxalate from the body and transfer it to the urine. In people with PH1, the excess oxalate can accumulate in the kidneys and cause kidney stones, as well as impede the normal functioning of the kidneys. The 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 ingredient 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 also decreases the levels of oxalate in the urine and blood. This may help to reduce the effects of the disease.

Oxlumo should not be administered:

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

Warnings and precautions

Consult your doctor before starting to receive this medication.

Your doctor may monitor you to detect signs of metabolic acidosis (accumulation of acid in the body) if you have severe kidney failure.

Other medications and Oxlumo

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or nurse before using this medication. Your doctor will decide whether you should take Oxlumo after considering the health benefits you would gain and the risks to your unborn baby.

Breastfeeding

This medication may pass into breast milk and affect your baby. If you are breastfeeding, consult your doctor for guidance before taking this medication. Your doctor will help you decide whether to stop breastfeeding or the treatment.

Driving and operating machines

It is unlikely that this medication will affect your ability to drive and use machines.

Oxlumo contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially “sodium-free”.

How much Oxlumo is administered

Your doctor will calculate the amount of medication to be administered. 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 dose) once a month in 3 doses. You will then begin to receive 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, administered once a month in 3 doses.
• Maintenance dose: 3 mg per kg of body weight, administered once a month starting one month after receiving the last loading dose.

Body weight of 10 kg to less than 20 kg

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

Body weight of 20 kg or more

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

How Oxlumo is administered

The medication will be administered by a doctor or nurse.

• The medication is administered as a subcutaneous injection in the abdominal area or, in some cases, in the upper arm or thigh. The injection will be administered in a different location each time.
• Depending on your dose, you may need to receive more than one subcutaneous injection.
• Your doctor or nurse will not administer the medication in areas of the skin with scars, redness, inflammation, or swelling.

If you use more Oxlumo than you should

In the unlikely event that your doctor or nurse administers too much medication (an overdose), they will monitor you for adverse effects.

If you forget to use Oxlumo

If you miss a dose of Oxlumo, consult with your doctor or nurse as soon as possible to coordinate the next dose.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not everyone experiences them.

The following adverse effects may occur when Oxlumo is administered:

Very Frequent:may affect more than 1 in 10 people

• Redness, pain, itching, inflammation, discomfort, color changes, mass, induration, rash, petechiae, or exfoliation at the injection site (injection site reaction).
• Abdominal pain or discomfort

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after “CAD”. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 30 °C.

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

Medications should not be disposed of through drains or in the trash. Your doctor or nurse will dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Oxlumo

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

Appearance of the product and contents of the pack

This medicine is a transparent, colorless to yellowish solution for subcutaneous injection.

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

Marketing authorization holder and responsible manufacturer

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: 09/2022

Other sources of information

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

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This information is intended solely for healthcare professionals:

Instructions for use

For subcutaneous administration only.

• Prepare the materials not included in the pack but required for administration, which will include a sterile syringe (0.3ml, 1ml, or 3ml), a G18 gauge needle, and a needle between G25 and G31.
• Calculate the required volume of Oxlumo based on the recommended dose according to weight. If the dose is greater than 0.5ml, you will need more than one vial. The maximum acceptable volume of a single injection that should be administered is 1.5ml. If you need more than 1.5ml, you may need to administer more than one subcutaneous injection.
• To extract Oxlumo, keep the vial in a vertical position or tilt it slightly and ensure that the flat end of the needle points downwards.
• Align the needle and syringe vertically and gently tap the syringe to allow the bubbles to rise to the top. Once the bubbles are at the top, press the plunger gently to force the bubbles out of the syringe. Check that there is the required amount of medicine in the syringe.
• Administer the medicine with a sterile syringe between G25 and G31, with a length of 13mm or 16mm for a subcutaneous injection. For volumes less than 0.3ml, a 0.3ml sterile syringe is recommended.
• Nota: Do not push the medicine towards the needle between G25 and G31. When using 0.3ml syringes (for insulin), do not force the bubbles out of the syringe.
• The injection can be administered in the abdomen, the upper arms, or the thighs. Consider alternating injection sites. Do not administer in scar tissue or in areas that are red, inflamed, or swollen.
• Nota: When administering subcutaneous injections in the abdomen, avoid administering within a 2.0cm diameter circle around the navel.
• Clean the area where you plan to administer the injection with an alcohol swab and wait for it to dry completely.
• Ensure that you use an appropriate injection technique. Do not inject into a vein or muscle.
• Insert the needle at the correct angle (90 degrees) to administer the injection just below the skin. In patients with limited subcutaneous tissue, the needle should be inserted at a 45-degree angle.
• Do not press the plunger while piercing the skin. Once the needle is inserted into the skin, release the pinched skin and administer the dose slowly and constantly. Once the medicine has been administered, count at least 5 seconds before removing the needle from the skin. Press gently with a gauze or cotton ball on the injection site, if necessary. Do not replace the needle cap.
• Nota: Do not aspirate after inserting the needle to prevent tissue damage, hematomas, and cardenals.
• If you need to administer more than one injection for a single dose of Oxlumo, the injection sites should be at least 2cm apart.
• Use the vial only once. After administering the dose, dispose of any unused medicine in the vial according to local regulations.
• Use syringes, transfer needles, and injection needles only once. Dispose of all used syringes and needles according to local regulations.