Source: FDA, National Drug Code (US) Revision Year: 2020
ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O42HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula:
ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride).
Inactive ingredients: Citric acid anhydrous, mannitol, sodium hydroxide.
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ALIQOPA is a lyophilized solid in a single-dose vial for reconstitution and further dilution for infusion. The labeled amount is 60 mg ALIQOPA per vial (reconstituted concentration of 15 mg/mL). |
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ALIQOPA is contained in a colorless glass vial closed with bromobutyl stopper with a flanged closure. Each vial of ALIQOPA contains copanlisib as a lyophilized solid.
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| Drug | Countries | |
|---|---|---|
| ALIQOPA | United States |
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