idelalisib - search results

United States - English - NLM (National Library of Medicine)

zydelig- idelalisib tablet, film coated

gilead sciences, inc. - idelalisib (unii: yg57i8t5m0) (idelalisib - unii:yg57i8t5m0) - idelalisib 100 mg - zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (cll) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. limitations of use zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with cll, small lymphocytic lymphoma (sll), follicular lymphoma (fl), and other indolent non-hodgkin lymphomas. zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with fl, sll, and other indolent non-hodgkin lymphomas. zydelig is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or patients with a history of toxic epidermal necrolysis with any drug [see warnings and precautions (5.6, 5.7)] . risk summary based on findings in animal studies and the mechanism of action [see clinical pharmac

Australia - English - Department of Health (Therapeutic Goods Administration)

zydelig idelalisib 150 mg tablet bottle

gilead sciences pty ltd - idelalisib, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; sodium starch glycollate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

Australia - English - Department of Health (Therapeutic Goods Administration)

zydelig idelalisib 100 mg tablet bottle

gilead sciences pty ltd - idelalisib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; hyprolose; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - ? zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

European Union - English - EMA (European Medicines Agency)

zydelig

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies.zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

New Zealand - English - Medsafe (Medicines Safety Authority)

zydelig

gilead sciences (nz) - idelalisib 100mg; - film coated tablet - 100 mg - active: idelalisib 100mg excipient: croscarmellose sodium hyprolose opadry orange 85f130017; formulation provided magnesium stearate microcrystalline cellulose sodium starch glycolate - zydelig is indicated in combination with rituximab for the treatment of patients with chronic lymphocytic leukaemia (cll)/small lymphocytic leukaemia (sll), including patients with 17p deletion or tp53 mutation, upon relapse after at least one prior therapy in patients for whom chemo-immunotherapy is not considered suitable. zydelig is not recommended for first-line treatment of cll/sll.