REVLIMID Capsules (2019)
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Περιεχόμενα
Name of the medicinal product
Revlimid 2.5 mg hard capsules. Revlimid 5 mg hard capsules. Revlimid 7.5 mg hard capsules. Revlimid 10 mg hard capsules. Revlimid 15 mg hard capsules. Revlimid 20 mg hard capsules. Revlimid 25 mg hard ...
Qualitative and quantitative composition
Revlimid 2.5 mg hard capsules: Each capsule contains 2.5 mg of lenalidomide. Excipient(s) with known effect: Each capsule contains 73.5 mg of lactose (as anhydrous lactose). Revlimid 5 mg hard capsules: ...
Pharmaceutical form
Hard capsule. Revlimid 2.5 mg hard capsules: Blue-green/white capsules, size 4, 14.3 mm, marked REV 2.5 mg. Revlimid 5 mg hard capsules: White capsules, size 2, 18.0 mm, marked REV 5 mg. Revlimid 7.5 mg ...
Therapeutic indications
Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid ...
Posology and method of administration
Revlimid treatment should be supervised by a physician experienced in the use of anti-cancer therapies. For all indications described below: Dose is modified based upon clinical and laboratory findings ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women who are pregnant. Women of childbearing potential unless all of the conditions of the Pregnancy Prevention ...
Special warnings and precautions for use
When lenalidomide is given in combination with other medicinal products, the corresponding Summary of Product Characteristics must be consulted prior to initiation of treatment. Pregnancy warning Lenalidomide ...
Interaction with other medicinal products and other forms of interaction
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with ...
Pregnancy and lactation
Due to the teratogenic potential, lenalidomide must be prescribed under a Pregnancy Prevention Programme (see section 4.4) unless there is reliable evidence that the patient does not have childbearing ...
Effects on ability to drive and use machines
Lenalidomide has minor or moderate influence on the ability to drive and use machines. Fatigue, dizziness, somnolence, vertigo and blurred vision have been reported with the use of lenalidomide. Therefore, ...
Undesirable effects
Summary of the safety profile Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with lenalidomide maintenance A conservative approach was applied to determine the adverse reactions ...
Overdose
There is no specific experience in the management of lenalidomide overdose in patients, although in dose- ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other immunosuppressants ATC code: L04AX04 Mechanism of action The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory ...
Pharmacokinetic properties
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+). Lenalidomide is produced as a racemic mixture. Lenalidomide is generally more soluble in ...
Preclinical safety data
An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day. Findings from this study indicate that lenalidomide produced external ...
List of excipients
Capsule contents: Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Capsule shell: Revlimid 2.5 mg/ 10 mg/ 20 mg hard capsules: Gelatin Titanium dioxide (E171) Indigo ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Polyvinylchloride (PVC) / Polychlorotrifluoroethylene (PCTFE) / Aluminium foil blisters containing 7 hard capsules. Revlimid 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules: Pack size of 7 or ...
Special precautions for disposal and other handling
Capsules should not be opened or crushed. If powder from lenalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water. If lenalidomide makes contact ...
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Marketing authorization number(s)
Revlimid 2.5 mg hard capsules: EU/1/07/391/005 EU/1/07/391/007 Revlimid 5 mg hard capsules: EU/1/07/391/001 EU/1/07/391/008 Revlimid 7.5 mg hard capsules: EU/1/07/391/006 EU/1/07/391/012 Revlimid 10 mg ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 June 2007 Date of latest renewal: 16 February 2017
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