KIMMTRAK tebentafusp 0.1 mg/0.5 mL concentrated solution for infusion vial Australia - English - Department of Health (Therapeutic Goods Administration)

kimmtrak tebentafusp 0.1 mg/0.5 ml concentrated solution for infusion vial

medison pharma australia pty ltd - tebentafusp, quantity: 0.2 mg/ml - injection, concentrated - excipient ingredients: citric acid monohydrate; water for injections; mannitol; trehalose dihydrate; polysorbate 20; dibasic sodium phosphate - kimmtrak is indicated for the treatment of hla-a02 01-positive adult patients with unresectable or metastatic uveal melanoma.

KIMMTRAK- tebentafusp injection, solution, concentrate United States - English - NLM (National Library of Medicine)

kimmtrak- tebentafusp injection, solution, concentrate

immunocore commercial llc - tebentafusp (unii: n658gy6l3e) (tebentafusp - unii:n658gy6l3e) - kimmtrak is indicated for the treatment of hla-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma. none. risk summary based on the mechanism of action, kimmtrak may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data with kimmtrak in pregnant woman. no animal reproductive and developmental toxicity studies have been conducted with kimmtrak. molecules of similar molecular weight can cross the placenta resulting in fetal exposure. advise women of the potential risk to the fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. risk summary there are no data on the presence of tebentafusp-tebn in human milk, the effect on the breastfed child, or the effects on milk production. because tebentafusp-tebn may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with kimmtrak and for at least 1 week after the last dose. kimmtrak may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating kimmtrak treatment. contraception females advise female of reproductive potential to use effective contraception during treatment and for 1 week following the last dose of kimmtrak [see use in specific populations (8.1)] . safety and efficacy of kimmtrak have not been established in pediatric patients. of the 245 patients with metastatic uveal melanoma treated with kimmtrak on imcgp100-202, 47% were 65 years of age and older and 9% were 75 years of age and older. no overall differences in safety or efficacy were observed between patients ≥ 65 years of age compared to younger adult patients.

Kimmtrak European Union - English - EMA (European Medicines Agency)

kimmtrak

immunocore ireland limited - tebentafusp - uveal neoplasms - antineoplastic agents - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

ALLERGIES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured, casein lactococcus lactis penicilium roquefort United States - English - NLM (National Library of Medicine)

allergies- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured, casein lactococcus lactis penicilium roquefort

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - cow milk 60 [hp_x] in 1 ml - allergies  formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset. formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

ALLERGIES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured, casein lactococcus lactis penicilium roquefort United States - English - NLM (National Library of Medicine)

allergies- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured, casein lactococcus lactis penicilium roquefort

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - cow milk 60 [hp_x] in 1 g - allergies  formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset. formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

DAIRY - GRAIN - NIGHTSHADES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact United States - English - NLM (National Library of Medicine)

dairy - grain - nightshades- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - cow milk 60 [hp_x] in 1 ml - formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods. formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

DAIRY - GRAIN - NIGHTSHADES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact United States - English - NLM (National Library of Medicine)

dairy - grain - nightshades- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - cow milk 60 [hp_x] in 1 g -  formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods. formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

DAIRY - GRAIN - NIGHTSHADES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact United States - English - NLM (National Library of Medicine)

dairy - grain - nightshades- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems. formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.

DAIRY - GRAIN - NIGHTSHADES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact United States - English - NLM (National Library of Medicine)

dairy - grain - nightshades- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lact

newton laboratories, inc. - cow milk (unii: 917j3173ft) (cow milk - unii:917j3173ft), skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a), cow milk fat (unii: 463jzs0xj3) (cow milk fat - unii:463jzs0xj3), casein, lactococcus lactis cultured, aged (unii: cjp9nl7jsj) (casein, lactococcus lactis cultured, aged - unii:cjp9nl7jsj), casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged (unii: iyi0g2057s) (casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged - unii:iyi0g2057s), casein, l - formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems. formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.

LAC DEFLORATUM- skim milk pellet United States - English - NLM (National Library of Medicine)

lac defloratum- skim milk pellet

boiron - skim milk (unii: 6a001y4m5a) (skim milk - unii:6a001y4m5a) - headache associated with constipation* stop use and ask a doctor if symptoms persist for more than 3 days or worsen