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GIVLAARI Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Givlaari 189 mg/mL solution for injection.

2. Qualitative and quantitative composition

Each mL of solution contains givosiran sodium equivalent to 189 mg givosiran. Each vial contains 189 mg givosiran. Excipients with known effect: For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection. Clear, colourless to yellow solution (pH of approximately 7.0; osmolality: 275-295 mOsm/kg).

4.1. Therapeutic indications

Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

4.2. Posology and method of administration

Therapy should be initiated under the supervision of a healthcare professional experienced in the management of porphyria. Posology The recommended dose of Givlaari is 2.5 mg/kg once monthly, administered ...

4.3. Contraindications

Severe hypersensitivity (e.g. anaphylaxis) to the active substance or to any excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Patients with AHP subtypes other than acute intermittent porphyria (AIP) The efficacy and safety data in patients with AHP subtypes other than AIP (hereditary coproporphyria (HCP), variegate porphyria ...

4.5. Interaction with other medicinal products and other forms of interaction

In a clinical drug-drug interaction study, givosiran resulted in a weak to moderate reduction in activity of certain CYP450 enzymes in the liver thereby increasing plasma exposures: CYP1A2: 1.3-fold increase ...

4.6. Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of givosiran in pregnant women. Studies in animals have shown reproductive toxicity in the presence of maternal toxicity (see section 5.3). ...

4.7. Effects on ability to drive and use machines

Givlaari 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 occurring adverse reactions reported in patients treated with givosiran are injection site reactions (ISRs) (36 %), nausea (32.4 %) and fatigue (22.5 %). ...

4.9. Overdose

No case of overdose has been reported. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: not yet assigned ATC code: not yet assigned Mechanism of action Givosiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of aminolevulinic ...

5.2. Pharmacokinetic properties

Absorption Following subcutaneous administration, givosiran is rapidly absorbed with a time to maximum plasma concentration (t<sub>max</sub>) of 0.5 to 2 hours. At the 2.5 mg/kg once monthly dose, the ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development. In the repeat-dose ...

6.1. List of excipients

Sodium hydroxide (pH adjustment) Phosphoric acid (pH adjustment) Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

3 years. Once the vial is opened, the medicinal product should be used immediately.

6.4. Special precautions for storage

Do not store above 25 °C. Keep vial in the outer carton to protect from light.

6.5. Nature and contents of container

Glass vial with a PTFE-coated chlorobutyl rubber stopper and a flip-off aluminium seal. Each vial contains 1 mL solution for injection. Pack size of one vial.

6.6. Special precautions for disposal and other handling

This medicinal product is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Alnylam Netherlands B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands

8. Marketing authorization number(s)

EU/1/20/1428/001

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