OXLUMO 94.5 mg/0.5 ml Injectable solution

Зміст інструкції

1. Oxlumo 94.5 mg/0.5 mL injectable solution
   1. What is Oxlumo and what it is used for
   2. What you need to know before you are given Oxlumo
   3. How Oxlumo is administered
   4. Possible side effects
   5. How to store Oxlumo
   6. Contents of the pack and other information

Oxlumo 94.5 mg/0.5 mL injectable solution

lumasiran

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Oxlumo and what it is 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 an excessive amount of a substance called
oxalate. The kidneys remove oxalate from the body through urine. In people with PH1, excess oxalate can accumulate in the kidneys and cause kidney stones, preventing the kidneys from functioning
correctly. Furthermore, an accumulation of oxalate can damage other parts of the body such as eyes,
heart, skin and bones. This condition is known as oxalosis.

How Oxlumo works
Lumasiran, the active substance of 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 the enzyme, the liver produces a lower amount of oxalate and also the levels of
oxalate in urine and blood decrease. This mechanism can help to reduce the effects
of the disease.

2. What you need to know before you are given Oxlumo

You must not receive 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 before you are given this medicine.
If you have severe kidney impairment, your doctor may monitor you to rule out signs of
metabolic acidosis (build-up of acid in the body).

Other medicines and Oxlumo
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, 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 the baby.

Breast-feeding
This medicine can pass into breast milk and may have effects on the 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 stop the treatment.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and operate
machinery.

Oxlumo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per mL, that is to say essentially ‘sodium-free’.

3. How Oxlumo is administered

How much Oxlumo is administered
The doctor will determine the amount of medicine to be administered to you. The dose will depend on your
body weight. The doctor will adjust the dose adapting it to weight changes.
You will receive the first doses (loading doses) once a month for 3 doses. Subsequently, maintenance
dosing will begin starting one month after the last loading dose.
Body weight less than 10 kg

• Loading doses: 6 mg for each kg of weight, administered once a month for 3 doses.
• Maintenance dosage: 3 mg for each kg of weight, administered once a month starting one month after the last loading dose.

Body weight between 10 kg and less than 20 kg

• Loading doses: 6 mg for each kg of weight, administered once a month for 3 doses.
• Maintenance dosage: 6 mg for each kg of weight, administered once every 3 months starting one month after the last loading dose.

Body weight of 20 kg and over

• Loading doses: 3 mg for each kg of weight, administered once a month for 3 doses.
• Maintenance dosage: 3 mg for each kg of weight, administered once every 3 months starting one month after the last loading dose.

How Oxlumo is administered
This medicine will be administered to you by the doctor or nurse.

• It is administered as an injection under the skin (subcutaneous) in the area of the stomach (abdomen) or, in some cases, in the upper arm or thigh. Each injection will be given at a different site.
• Depending on the dose, more than one subcutaneous injection may be necessary.
• The doctor or nurse will not administer the injection into areas of skin that are scarred, red, inflamed, or swollen.

If you are given too much Oxlumo
In the unlikely event that the doctor or nurse administers a quantity higher than due
(overdose), you will be monitored to check for any occurrence of undesirable
effects.

If you miss a dose of Oxlumo
If you miss a dose of Oxlumo, contact your doctor or nurse as soon as possible to agree on the
administration of the next dose.
If you have any doubts about the use of this medicine, contact 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 during the intake of Oxlumo.

Very common:may affect more than 1 in 10 people

• Redness, pain, itching, swelling, discomfort, colour changes, mass, hardening, rash, bruising or flaking at the injection site (injection site reaction).
• Abdominal pain or discomfort.

Not known: frequency cannot be estimated based on the available data

• A type of allergic reaction (hypersensitivity), with symptoms such as rash, sore throat and watering eyes.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. 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. How to store 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 pack and vial after
Expiry./EXP. The expiry date refers to the last day of that month.
This medicine is for single use only. Once the vial has been opened, it must be
used immediately.
Do not store at a temperature above 30°C.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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 of lumasiran.
• The other components are water for injections, sodium hydroxide (E524) and phosphoric acid (E338) (see “Oxlumo contains sodium” in section 2).

Description of Oxlumo and contents of the pack
This medicine is a transparent, colourless to yellow solution for subcutaneous injections.
Each pack contains one single-use vial containing 0.5 mL of solution.

Marketing Authorisation Holder and Manufacturer
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
For further information on this medicine, contact 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]

Lietuva
Medison Pharma Lithuania UAB
Tel: +31 20 369 7861
[email protected]

България
Genesis Pharma Bulgaria EOOD
Teл.: +359 2 969 3227
[email protected]

Luxembourg/Luxemburg
Alnylam Netherlands B.V.
Tél/Tel: 80085235 (+352 203 014 48)
[email protected]

Česká 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]

Danmark
Alnylam Sweden AB
Tlf.: 433 105 15 (+45 787 453 01)
[email protected]

Malta
Genesis Pharma (Cyprus) Ltd
Tel: +357 22765715
[email protected]

Deutschland
Alnylam Germany GmbH
Tel: 08002569526 (+49 8920190112)
[email protected]

Nederland
Alnylam Netherlands B.V.
Tel: 08002820025 (+31 203697861)
[email protected]

Eesti
Medison Pharma Estonia OÜ
Tel: +31 20 369 7861
[email protected]

Norge
Alnylam Sweden AB
Tlf: 800 544 00 (+472 1405 657)
[email protected]

Ελλάδα
ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε
Τηλ: +30 210 87 71 500
[email protected]

Österreich
Alnylam Austria GmbH
Tel: 0800070339 (+43 720 778 072)
[email protected]

España
Alnylam Pharmaceuticals Spain SL
Tel: 900810212 (+34 910603753)
[email protected]

Polska
Medison Pharma Sp. z o.o.
Tel.: +31 20 369 7861
[email protected]

France
Alnylam France SAS
Tél: 0805542656 (+33 187650921)
[email protected]

Portugal
Alnylam Portugal
Tel: 707201512 (+351 21 269 8539)
[email protected]

Hrvatska
Genesis Pharma Adriatic d.o.o
Tel: +385 1 5530 011
[email protected]

România
Genesis Biopharma Romania SRL
Tel: +40 21 403 4074
[email protected]

Ireland
Alnylam Netherlands B.V.
Tel: 1800 924260 (+353 818 882213)
[email protected]

Slovenija
Genesis Biopharma SL d.o.o
Tel: +386 1 292 70 90
[email protected]

Ísland
Alnylam Netherlands B.V.
Sími: +31 20 369 7861
[email protected]

Slovenská republika
Medison Pharma s.r.o.
Tel: +31 20 369 7861
[email protected]

Italia
Alnylam Italy S.r.l.
Tel: 800 90 25 37 (+39 02 89 73 22 91)
[email protected]

Suomi/Finland
Alnylam Sweden AB
Puh/Tel: 0800 417 452 (+358 942 727 020)
[email protected]

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: +357 22765715
[email protected]

Sverige
Alnylam Sweden AB
Tel: 020109162 (+46 842002641)
[email protected]

Latvija
Medison Pharma Latvia SIA
Tel: +31 20 369 7861
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu/ .
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The following information is intended exclusively for healthcare professionals:
Instructions for use
For subcutaneous use only.

• Prepare the materials not included in the pack necessary for administration, namely 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 dosage in relation to body weight. If the dose is greater than 0.5 mL, more than one vial will be needed. The maximum acceptable volume for a single injection is 1.5 mL. If more than 1.5 mL is required, more than one subcutaneous injection may be necessary.
• Use an 18 G needle to draw Oxlumo from the vial; hold the vial upright or slightly tilted and ensure that the flat end of the needle is facing downwards.
• Point the needle and syringe upwards and tap the syringe to allow any air bubbles to rise. Then, gently push the plunger to expel the air bubbles from the syringe. Verify that the syringe contains the correct amount of medicine.
• Administer the medicine with a sterile 25 G to 31 G needle and a length of 13 mm or 16 mm for subcutaneous injection. For volumes less than 0.3 mL, the use of a 0.3 mL sterile syringe is recommended.
• Note: do not push the medicine into the 25 G to 31 G needle. When using a 0.3 mL (insulin) syringe, do not force the expulsion of air bubbles from the syringe.
• The injection can be given in the abdomen, upper arms or thighs. Alternate injection sites. Do not administer the medicine into scar tissue or areas that are red, inflamed or swollen.
• Note: when performing a subcutaneous injection in the abdomen, avoid an area of 2 cm in diameter around the navel.
• Clean the injection site with an alcohol swab and wait for it to dry completely.
• Take care to use a correct injection technique. Do not inject into a vein or muscle.
• Insert the needle at a right angle (90 degrees) to deliver the solution just below the skin. In patients with poor subcutaneous tissue, insert the needle at a 45-degree angle.
• Do not push the plunger while puncturing the skin. Once the needle is inserted into the skin, release the pinched skin and administer the dose slowly and steadily. After administering this medicine, wait at least 5 seconds before removing the needle from the skin. Gently press gauze or cotton wool on the injection site if necessary. Do not recap the needle.
• Note: do not aspirate after inserting the needle to avoid tissue damage, hematoma and bruising.
• If more than one injection is needed for a single dose of Oxlumo, the injection sites must be at least 2 cm apart.
• Use the vial only once. Once the dose has been administered, dispose of any unused medicine in the vial according to local regulations.
• Use syringes, transfer needles and injection needles only once. Dispose of used syringes and needles according to local regulations.