Venetoclax (Venclexta)

Trade Name : Venclexta

AbbVie Inc.

TABLET, FILM COATED

Strength 10 mg/1

VENETOCLAX BCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Venetoclax (Venclexta) which is also known as Venclexta and Manufactured by AbbVie Inc.. It is available in strength of 10 mg/1 per ml. Read more

Venetoclax (Venclexta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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VENCLEXTA is a BCL-2 inhibitor indicated:
This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ()

For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ()
In combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

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See Full Prescribing Information for recommended VENCLEXTA starting and ramp-up dosages. ()
VENCLEXTA tablets should be taken orally once daily with a meal and water. Do not chew, crush, or break tablets. ()
Perform prophylaxis for tumor lysis syndrome. ()

Tablets: 10 mg, 50 mg, 100 mg ()

Concomitant use of VENCLEXTA with CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients with CLL/SLL due to the potential for increased risk of tumor lysis syndrome .
Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated. (, , )

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Tumor Lysis Syndrome (TLS): Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics and ensure adequate hydration. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases. (, )
Neutropenia: Monitor blood counts and for signs of infection; manage as medically appropriate. (, )
Infections: Monitor for signs and symptoms of infection and treat promptly. Withhold treatment for Grade 3 and higher infection until resolution. ()
Immunization: Do not administer live attenuated vaccines prior to, during, or after VENCLEXTA treatment. ()
Embryo-Fetal Toxicity: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment. n
Treatment of patients with multiple myeloma with VENCLEXTA in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials. ()

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.
In CLL/SLL, the most common adverse reactions (u226520%) for VENCLEXTA when given in combination with obinutuzumab or rituximab or as monotherapy were neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema. ()n n
In AML, the most common adverse reactions (u226530%) in combination with azacitidine or decitabine or low-dose cytarabine were nausea, diarrhea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, peripheral edema, pyrexia, pneumonia, dyspnea, hemorrhage, anemia, rash, abdominal pain, sepsis, back pain, myalgia, dizziness, cough, oropharyngeal pain, and hypotension. ()n n
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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Strong or moderate CYP3A inhibitors or P-gp inhibitors: Adjust dosage of VENCLEXTA. (, )
Strong or moderate CYP3A inducers: Avoid co-administration. ()
P-gp substrates: Take at least 6 hours before VENCLEXTA. ()

No data

Lactation: Advise women not to breastfeed. ()
Hepatic Impairment: Reduce the VENCLEXTA dose by 50% in patients with severe hepatic impairment. (, )

There is no specific antidote for VENCLEXTA. For patients who experience overdose, closely monitor and provide appropriate supportive treatment; during ramp-up phase interrupt VENCLEXTA and monitor carefully for signs and symptoms of TLS along with other toxicities . Based on venetoclax large volume of distribution and extensive protein binding, dialysis is unlikely to result in significant removal of venetoclax.

Venetoclax is a selective inhibitor of BCL-2 protein. It is a light yellow to dark yellow solid with the empirical formula CHClNOS and a molecular weight of 868.44. Venetoclax has very low aqueous solubility. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)--({3-nitro-4-[(tetrahydro-2-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1-pyrrolo[2,3-]pyridin-5-yloxy)benzamide) and has the following chemical structure:
VENCLEXTA tablets for oral administration are supplied as pale yellow or beige tablets that contain 10, 50, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with u201cVu201d on one side and u201c10u201d, u201c50u201d or u201c100u201d corresponding to the tablet strength on the other side.

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VENCLEXTA is dispensed as follows:
VENCLEXTA 10 mg film-coated tablets are round, biconvex shaped, pale yellow debossed with u201cVu201d on one side and u201c10u201d on the other side.
VENCLEXTA 50 mg film-coated tablets are oblong, biconvex shaped, beige debossed with u201cVu201d on one side and u201c50u201d on the other side.
VENCLEXTA 100 mg film-coated tablets are oblong, biconvex shaped, pale yellow debossed with u201cVu201d on one side and u201c100u201d on the other side.
Store at or below 86u00b0F (30u00b0C).

Advise the patient to read the FDA-approved patient labeling ().
Instructions for Taking VENCLEXTA
Advise patients to take VENCLEXTA exactly as prescribed and not to change their dose or to stop taking VENCLEXTA unless they are told to do so by their HCP. Advise patients to take VENCLEXTA orally once daily, at approximately the same time each day, according to their HCP's instructions and that the tablets should be swallowed whole with a meal and water without being chewed, crushed, or broken .
Advise patients with CLL/SLL to keep VENCLEXTA in the original packaging during the first 4 weeks of treatment, and not to transfer the tablets to a different container.
Advise patients that if a dose of VENCLEXTA is missed by less than 8 hours, to take the missed dose right away and take the next dose as usual. If a dose of VENCLEXTA is missed by more than 8 hours, advise patients to wait and take the next dose at the usual time .
Advise patients not to take any additional dose that day if they vomit after taking VENCLEXTA, and to take the next dose at the usual time the following day.
Manufactured and Marketed by:AbbVie Inc.North Chicago, IL 60064
and
Marketed by:Genentech USA, Inc.A Member of the Roche GroupSouth San Francisco, CA 94080-4990n
u00a9 2019 AbbVie Inc.u00a9 2019 Genentech, Inc.03-B947 July 2019

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NDC 0074-0579-28
CLL/SLL Starting Pack
VENCLEXTAu00ae
(venetoclax tablets)
10 mg, 50 mg, and 100 mg
Starting Pack
! WARNING
Contact your doctor when you receive this medication.
It may be necessary to take your first dose in the presence of your doctor to prevent a potential serious side effect.
DISPENSER:
abbvie
Rx only
Genentech
NDC 0074u20130561u201314
Rx only
VENCLEXTAu00ae
(venetoclax tablets)
10 mg
14 Tablets
Dispense the accompanying Medication Guide to each patient.
abbvie
Genentech
NDC 0074-0566-11
Rx only
VENCLEXTAu00ae
(venetoclax tablets)
50 mg
1 Tablet
Dispense the accompanying Medication Guide to each patient.
abbvie
Genentech
NDC 0074-0576-22
Rx only
VENCLEXTAu00ae
(venetoclax tablets)
100 mg
120 Tablets
Do not accept if seal over bottle opening is broken or missing.
Each film-coated tablet contains 100 mg of venetoclax.
Keep out of reach of children.
Store at or below 86u00b0F (30u00b0C).
abbvie
Genentech
NDC 0074-0576-22
Rx only
VENCLEXTAu00ae
(venetoclax tablets)
100 mg
120 Tablets
Dispense the accompanying Medication Guide to each patient.
abbvie
Genetech
NDC 0074u20130576u201311
Rx only
VENCLEXTAu00ae
(venetoclax tablets)
100 mg
1 Tablet
Dispense the accompanying Medication Guide to each patient.
abbvie
Genetech

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Venetoclax (Venclexta)

Trade Name : Venclexta

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Venetoclax (Venclexta)

Trade Name : Venclexta

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?