PIVIKTO

This brand name is authorized in Nigeria. It is also authorized in South Africa.

Active ingredients

The drug PIVIKTO contains one active pharmaceutical ingredient (API):

1	Alpelisib UNII 08W5N2C97Q - ALPELISIB
	Alpelisib is an α-specific class I phosphatidylinositol3kinase (PI3Kα) inhibitor. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and AKT-signalling, cellular transformation and the generation of tumours in in vitro and in vivo models.
	Read more about Alpelisib

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100496	Tablet	Pivikto 200mg + 50mg Film Coated Tablets TAB 200mg + 50mg 14 x 200mg + 14 x 50mg, 28 x 200mg + 28 x 50mg	Pivikto 200mg + 50mg Film Coated Tablets Alpelisib Light pink, unscored, round and curved with beveled edges, imprinted with “L7” on one side and “NVR” on the other side; Alpelisib 50mg; Microcrystalline cellulose (PH102) 26.60mg; D-Mannitol 23mg; Microcrystalline cellulose  (PH101) 11.4mg; Sodium starch glycolate (Type A) 5mg; Hypromellose 3mg; Magnesium stearate 2mg; Coating premix black 0.018mg - (Hypromellose 0.013mg; Iron oxide, black (E 172), Ferrosoferric oxide 0.003mg; Macrogol 4000, Polyethylene glycol (PEG) 4000 0.001mg; Talc 0.001 14 x 200mg + 14 x 50mg, 28 x 200mg + 28 x 50mg Prescription Only Medicine (POM) 15/03/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS Novartis Pharma Stein AG, Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein AG, Switzerland, Switzerland	31/08/2023
A4-100514	Film coated tablet	Pivikto 150mg Film Coated Tablet TAB_FILM_COATED 150 mg 28 x 150mg, 56 x 150mg	Pivikto 150mg Film Coated Tablet Alpelisib Alpelisib 150mg; Microcrystalline cellulose (PH102) 79.8mg; D-Mannitol 69mg; Microcrystalline cellulose  (PH101) 34.2mg; Sodium starch glycolate (Type A) 15mg; Hypromellose 9mg; Magnesium stearate 6mg; Coating premix black 0.079mg - (Hypromellose 0.056mg; Iron oxide, black (E 172), Ferrosoferric oxide 0.011mg; Macrogol 4000, Polyethylene glycol (PEG) 4000 0.006mg; Talc 0.006mg); Coating premix red 0.476mg - (Hypromellose 0.340mg; Iron oxide, red (E 172), Red ferric oxide 0.068mg; Macrogol 4000, 28 x 150mg, 56 x 150mg Prescription Only Medicine (POM) 15/03/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS Novartis Farma S.P.A, Novartis Farma S.P.A Torre Annunziata, Italy, Switzerland	31/08/2023
A4-100515	Tablet	Pivikto 200mg Film Coated Tablet TAB 200 mg 14,28	Pivikto 200mg Film Coated Tablet Alpelisib Alpelisib 200mg; Microcrystalline cellulose (PH102) 106.4mg; D-Mannitol 92mg; Microcrystalline cellulose  (PH101) 45.6mg; Sodium starch glycolate (Type A) 20mg; Hypromellose 12mg; Magnesium stearate 8mg; Coating premix black 0.123mg - (Hypromellose 0.088mg; Iron oxide, black (E 172), Ferrosoferric oxide 0.018mg; Macrogol 4000, Polyethylene glycol (PEG) 4000 0.009mg; Talc 0.009mg); Coating premix red 1.131mg - (Hypromellose 0.808mg; Iron oxide, red (E 172), Red ferric oxide 0.162mg; Macrogol 400 14,28 POM 2 15/03/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS Novartis Pharma Stein AG, Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein AG, Switzerland, Switzerland	31/08/2023

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
L01EM03		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
Discover more medicines within L01EM03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
NG	Registered Drug Product Database	A4-100496, A4-100514, A4-100515
ZA	Health Products Regulatory Authority	55/26/0290, 55/26/0291, 55/26/0292