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

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting treatment with kymriah. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - cladribine 1 mg/ml - solution for infusion - 1 mg/ml - active: cladribine 1 mg/ml excipient: sodium chloride water for injection - leustatin is indicated in the treatment of patients with hairy cell leukaemia (hcl).

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

atnahs pharma australia pty ltd - cladribine, quantity: 10 mg - injection, concentrated - excipient ingredients: dibasic sodium phosphate heptahydrate; phosphoric acid; water for injections; sodium chloride - leustatin is indicated for the treatment of patients with hairy cell leukaemia. it is also indicated for the treatment of patients with b-cell chronic lymphocytic leukaemia in whom treatment with alkylating agents has failed.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - other antineoplastic agents - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse.• adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy.• adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

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

prometheus laboratories inc. - aldesleukin (unii: m89n0q7eqr) (aldesleukin - unii:m89n0q7eqr) - aldesleukin 1.1 mg in 1 ml - proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic rcc). proleukin is indicated for the treatment of adults with metastatic melanoma. careful patient selection is mandatory prior to the administration of proleukin. see “contraindications ”, “warnings ” and “precautions ” sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests. evaluation of clinical studies to date reveals that patients with more favorable ecog performance status (ecog ps 0) at treatment initiation respond better to proleukin, with a higher response rate and lower toxicity (see “clinical pharmacology ” section, “clinical studies ” section and “adverse reactions ” section). therefore, selection of patients for treatment should include assessment of performance status. experience in patients with ecog ps >1 is extremely limited. proleukin® (aldesleukin) is contraindicated in patients with a known history of hypersensit

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

organon pharma pty ltd - betamethasone dipropionate, quantity: 0.64 mg/g (equivalent: betamethasone, qty 0.5 mg/g) - ointment - excipient ingredients: white soft paraffin; liquid paraffin - topical treatment of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lechen planus, intertrigo and psoriasis. indications as at 26 august 1992: eleuphrat is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.

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

organon pharma pty ltd - betamethasone dipropionate, quantity: 0.64 mg/g (equivalent: betamethasone, qty 0.5 mg/g) - cream - excipient ingredients: phosphoric acid; cetostearyl alcohol; white soft paraffin; sodium hydroxide; cetomacrogol 1000; purified water; liquid paraffin; chlorocresol; monobasic sodium phosphate dihydrate - topical treatment of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis. indications as at 26 august 1992: eleuphrat is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.

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

clinigen limited - aldesleukin (unii: m89n0q7eqr) (aldesleukin - unii:m89n0q7eqr) - proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (rcc). proleukin is indicated for the treatment of adults with metastatic melanoma. - severe hypersensitivity reactions proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the proleukin formulation [see adverse reactions (6.2)]. - organ allografts proleukin is contraindicated in patients with organ allografts [see warnings and precautions (5.5)] . - significant organ impairment proleukin is contraindicated in patients with significant cardiac (including those with an abnormal cardiac ejection fraction, impaired wall motion, or significant coronary artery disease), pulmonary (including those with an fev1 ≤ 2 liters or < 75% predicted for height and age), renal, hepatic, or cns impairment [see warnings and precautions (5.1, 5.2, 5.4)] . risk summary based on findings in an animal study and its mechanism of action, proleukin may cause fetal harm or los

Israel - English - Ministry of Health

megapharm ltd - aldesleukin - powder for solution for infusion - aldesleukin 18 miu - aldesleukin - proleukin (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic rcc). proleukin is indicated for the treatment of adults with metastatic melanoma.careful patient selection is mandatory prior to the administration of proleukin.

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -