Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - oxlumo

Document Subject

Generated Narrative: MedicinalProductDefinition mp1f87461293bc326acebf2dcaabf7857f

identifier: http://ema.europa.eu/identifier/EU/1/20/1496/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Oxlumo 94.5 mg/0.5 mL solution for injection.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1f87461293bc326acebf2dcaabf7857f

identifier: http://ema.europa.eu/identifier/EU/1/20/1496/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - oxlumo

Attesters

What is in this leaflet:

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

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.

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 before being 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.

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 using 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 sodium-free .

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 Oxlumo is given

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.

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.

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)

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 vial in the outer carton 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.

What Oxlumo contains

• The active substance is lumasiran.
• Each vial contains lumasiran sodium equivalent to 94.5 mg lumasiran.
• The other ingredients are water for injections, sodium hydroxide, and phosphoric acid (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 1083 HP Amsterdam
Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Alnylam Netherlands B.V. T l/Tel: 0800 81 443 (+32 234 208 71) medinfo@alnylam.com

Malta Genesis Pharma (Cyprus) Ltd Tel: +357 22765medinfo@genesispharmagroup.com

Genesis Pharma Bulgaria EOOD Te .: +359 2 969 3medinfo@genesispharmagroup.com

Nederland Alnylam Netherlands B.V. Tel: 08002820025 (+31 203697861) medinfo@alnylam.com

esk republika Alnylam Czech s.r.o. Tel: 800 050 450 (+420 234 092 195) medinfo@alnylam.com

Norge Alnylam Sweden AB Tlf: 800 544 00 (+472 1405 657) medinfo@alnylam.com

Danmark Alnylam Sweden AB Tlf: 433 105 15 (+45 787 453 01) medinfo@alnylam.com

sterreich Alnylam Austria GmbH Tel: 0800070339 (+43 720 778 072) medinfo@alnylam.com

Deutschland Portugal Alnylam Germany GmbH Tel: 08002569526 (+49 8920190112) medinfo@alnylam.com

Alnylam Portugal Tel: 707201512 (+351 707502642) medinfo@alnylam.com

 .  

: +30 210 87 71 medinfo@genesispharmagroup.com

Rom nia Genesis Biopharma Romania SRL Tel: +40 21 403 4medinfo@genesispharmagroup.com

Espa a Alnylam Pharmaceuticals Spain SL Tel: 900810212 (+34 910603753) medinfo@alnylam.com

Slovenija Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 medinfo@genesispharmagroup.com

France Alnylam France SAS T l: 0805542656 (+33 187650921) medinfo@alnylam.com

Suomi/Finland Alnylam Sweden AB Puh/Tel: 0800 417 452 (+358 942 727 020) medinfo@alnylam.com

Hrvatska Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 medinfo@genesispharmagroup.com

Sverige Alnylam Sweden AB Tel: 020109162 (+46 842002641) medinfo@alnylam.com

Italia Alnylam Italy S.r.l. Tel: 800 90 25 37 (+39 02 89 73 22 91) medinfo@alnylam.com

United Kingdom (Northern Ireland) Alnylam UK Ltd. Tel: 08001412569 (+44 1628 878592) medinfo@alnylam.com

Ireland Alnylam Netherlands B.V. Tel: 1800 924260 (+353 818 882213) medinfo@alnylam.com

Eesti, sland, Latvija, Lietuva, Magyarorsz g, Polska, Slovensk republika Alnylam Netherlands B.V. Tel/S mi: +31 20 369 7medinfo@alnylam.com

Genesis Pharma (Cyprus) Ltd : +357 22765medinfo@genesispharmagroup.com

Luxembourg/Luxemburg Alnylam Netherlands B.V. T l/Tel: 80085235 (+352 203 014 48) medinfo@alnylam.com

This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: