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ZYDELIG Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zydelig 100 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of idelalisib. Excipient with known effect: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4). For the full list of excipients, see section ...

Pharmaceutical form

Film-coated tablet. Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with GSI and 100 on the other side.

Therapeutic indications

Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy (see section 4.4), or as first ...

Posology and method of administration

Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies. Posology The recommended dose is 150 mg idelalisib twice daily. Treatment should be continued ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Serious infections Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection. Serious and fatal infections have occurred with ...

Interaction with other medicinal products and other forms of interaction

Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4). Its primary metabolite is GS-563117, which is not pharmacologically active. Idelalisib ...

Fertility, pregnancy and lactation

Women of childbearing potential / contraception Based on findings in animals, idelalisib may cause foetal harm. Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Phase 1 and 2 studies. Study 312-0116 was a randomised, double-blind, ...

Overdose

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents ATC code: L01XX47 Mechanism of action Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive ...

Pharmacokinetic properties

Absorption Following oral administration of a single dose of idelalisib, peak plasma concentrations were observed 2 to 4 hours post-dose under fed conditions and after 0.5 to 1.5 hours under fasted conditions. ...

Preclinical safety data

Repeated dose toxicity Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue. In general, B-lymphocyte dependent areas were more affected than T-lymphocyte ...

List of excipients

Tablet core: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate Film-coating: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil. Each carton contains 1 bottle.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization number(s)

EU/1/14/938/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019

Πηγαίο έγγραφο

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