KESIMPTA Solution for injection (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Kesimpta 20 mg solution for injection in pre-filled syringe. Kesimpta 20 mg solution for injection in pre-filled pen.

2. Qualitative and quantitative composition

Kesimpta 20 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml). Kesimpta 20 mg solution for injection in pre-filled ...

3. Pharmaceutical form

Solution for injection (injection). Solution for injection (injection) in pre-filled pen (Sensoready Pen). The solution is clear to slightly opalescent, and colourless to slightly brownish-yellow.

4.1. Therapeutic indications

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).

4.2. Posology and method of administration

Treatment should be initiated by a physician experienced in the management of neurological conditions. Posology The recommended dose is 20 mg ofatumumab administered by subcutaneous injection with: initial ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients in a severely immunocompromised state (see section 4.4). Severe active infection until resolution (see ...

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Injection-related reactions Patients ...

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

No interaction studies have been performed, as no interactions are expected via cytochrome P450 enzymes, other metabolising enzymes or transporters. Vaccinations The safety of and the ability to generate ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) while receiving Kesimpta and for 6 months after ...

4.7. Effects on ability to drive and use machines

Kesimpta has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most important and frequently reported adverse reactions are upper respiratory tract infections (39.4%), systemic injection-related reactions (20.6%), injection-site reactions ...

4.9. Overdose

Doses up to 700 mg have been administered in clinical studies with MS patients without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: selective immunosuppressants ATC code: L04AA52 Mechanism of action Ofatumumab is a fully human anti-CD20 monoclonal immunoglobulin G1 (IgG1) antibody. The CD20 ...

5.2. Pharmacokinetic properties

Absorption A monthly subcutaneous dose of 20 mg leads to a mean AUCtau of 483 µg*h/ml and a mean Cmax of 1.43 µg/ml at steady state. After subcutaneous administration, ofatumumab ...

5.3. Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints. Neither carcinogenicity nor mutagenicity studies ...

6.1. List of excipients

L-arginine Sodium acetate trihydrate Sodium chloride Polysorbate 80 Disodium edetate dihydrate Hydrochloric acid (for 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

2 years.

6.4. Special precautions for storage

Kesimpta 20 mg solution for injection in pre-filled syringe: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. ...

6.5. Nature and contents of container

Kesimpta 20 mg solution for injection in pre-filled syringe: Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield. ...

6.6. Special precautions for disposal and other handling

Instructions for handling of the pre-filled syringe Before injection, the pre-filled syringe should be taken out of the refrigerator for about 15 to 30 minutes to allow it to reach room temperature. The ...

7. Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

8. Marketing authorization number(s)

EU/1/21/1532/001-004

9. Date of first authorization / renewal of the authorization

26 March 2021

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