What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Zejula (Niraparib)
Prescription Required
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Product Details
Description
Your doctor may prescribe Zejula for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Zejula is a poly (ADP-ribose) polymerase (PARP) inhibitor. These drugs work by interfering with the DNA repair mechanisms in cancer cells, ultimately leading to cell death and slowing the progression of the disease.
Fact Table
Formula
C19H20N4O5
License
US FDA, EMA
Bioavailability
73%
Legal status
Prescription only (?)
Chemical Name
2-[4-[(3S)-3-piperidinyl]phenyl]-2H-indazole-7-carboxamide
Elimination half-life
36 hours
Dosage (Strength)
100 mg capsules
Pregnancy
Contraindicated
Brands
Zejula
Protein binding
83%
PubChem CID
24958200
MedlinePlus
a617038
ChEBI
CHEBI:134722
ATC code
L01XX54
DrugBank
DB12362
KEGG
D10867
Routes of administration
Oral
Directions
The usual dosage is 200-300 mg by mouth once daily. Zejula may be taken with or without food.
Ingredients
The active ingredient in Zejula is niraparib.
Interactions
There are no significant drug-drug interactions with Zejula
Cautions
Cardiovascular side effects like changes in blood pressure and heart rate can occur. Patients should have their blood pressure and heart rate monitored at least weekly for the first two months, then monthly for the first year, and periodically thereafter. Management may include the use of antihypertensive medications and adjustments to the Zejula dose if necessary.
Zejula has been associated with cases of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), some of which have been fatal. It is crucial to monitor patients for hematological toxicity and discontinue the medication if MDS/AML is confirmed.
Bone marrow suppression is a significant risk. It is recommended to test blood counts weekly for the first month, then monthly for eleven months, and then periodically thereafter to monitor for clinically significant changes.
Zejula can cause harm to a fetus. Females of reproductive potential should be advised of the potential risks to a fetus and the necessity of using effective contraception while on this medication.
Side Effects
Common adverse effects of Zejula may include:
- Acute myeloid leukemia
- Anemia
- Anemia, Grade 3 or 4
- Constipation
- Decrease in appetite
- Dyspnea
- Gastrointestinal perforation
- Headache
- Hypertension
- Hypertensive crisis
- Insomnia
- Leukopenia, Grade 3 or 4
- Myelodysplastic syndrome
- Nasopharyngitis
- Nausea
- Neutropenia
- Neutropenia, Grade 3 or 4
- Pancytopenia
- Perforation of small intestine
- Pleural effusion
- Posterior reversible encephalopathy syndrome
- Rash
- Thrombocytopenia
- Thrombocytopenia, Grade 3 or 4
- Vomiting
References
Zejula [package insert]. Research Park Triangle, NC: GlaxoSmithKline; April 2020.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14607
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