Zejula

About Niraparib or Zejula

• Niraparib, marketed as Zejula, is an oral anti-cancer medication approved by the FDA on March 27, 2017. Niraparib is an antineoplastics which belongs to the family called as PARP Inhibitors. 
• As a PARP inhibitor, it is prescribed for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. 
• Zejula is specifically indicated for the maintenance treatment of adult patients who have responded to first-line platinum-based chemotherapy and those with recurrent disease who have shown a complete or partial response to platinum-based chemotherapy.
• PARP proteins play a crucial role in aiding damaged cells in self-repair. Niraparib functions by inhibiting the activity of PARP proteins, preventing their normal functioning. 
• This inhibition disrupts the repair mechanism, potentially causing cancer cells to accumulate irreparable damage, leading to their demise.

Strength: 

Bottle of 90 and 30 Niraparib capsules are delivered in a strength of 100 mg respectively for oral consumption. 

Recommended Dosage:

The Niraparib capsules must be taken at the  same time each day until disease progression or unacceptable toxicity. The capsules must not be broken, chewed, or split but swallowed as whole. Niraparib capsules can be swallowed with or without food. 

• The recommended dose is 200 mg (two 100-mg capsules) given orally once daily for patients weighing less than 77 kg (170 lbs) OR with a platelet count of less than 150,000/L.
• The recommended dose is 300 mg (three 100-mg capsules) given orally once daily for patients weighing greater than 77 kg (170 lbs) OR with a platelet greater than or equal to 150,000/μL.

Important: Patients must consult their treating doctor in case of experiencing any severe reactions. 

Warnings & Precautions

• Patients following the Niraparib treatment have developed MDS/AML, some of which were fatal. It is necessary to assess patients for hematological damage and discontinue the treatment if MDS/ AML (Myelodysplastic Syndrome/Acute Myeloid Leukemia) is found.
• For the first month, it is necessary to monitor the total blood count every week (Bone Marrow Suppression). This administration can be followed by an every month monitoring for the next 11 months, and then, check often for clinically significant changes.
• For the two initial months, it is necessary to monitor the blood pressure weekly (Cardiovascular effects). This can be followed by a monthly administration for the first year and periodically during the Niraparib treatment. 
• Females with the potential of reproduction must be advised to take effective contraception as Niraparib capsules can cause fetal harm (Embryo-fetal toxicity). 

Common Niraparib Side Effects

• Nausea
• Thrombocytopenia
• Anemia
• Fatigue
• Constipation
• Musculoskeletal pain
• Abdominal pain
• Vomiting
• Neutropenia
• Decreased appetite
• Leukopenia
• Insomnia
• Headache
• Dyspnea
• Rash
• Diarrhea
• Hypertension
• Cough
• Dizziness
• Acute kidney injury
• Urinary tract infection
• Hypomagnesemia

Use in Specific Population

• Due to its mechanism of action, Zejula has the potential to cause fetal harm if administered to pregnant women.
• There is a lack of data concerning the presence of niraparib or its metabolites in human milk, as well as their impact on breastfeeding infants and milk production. As a precaution against serious adverse reactions in breastfed infants, lactating women are advised not to breastfeed during Zejula treatment and for one month after the final dose. 
• Prior to initiating Zejula treatment, it is recommended to confirm the pregnancy status of females of reproductive potential. 
• Additionally, females of reproductive potential should employ effective contraception during Zejula treatment and for at least six months following the last dose. 
• Animal studies suggest that Zejula may affect male fertility. 
• The safety and effectiveness of Zejula in pediatric patients have not been established, and while no significant differences were observed in older individuals, their potential heightened sensitivity cannot be ruled out. 
• Dose adjustment is unnecessary for patients with mild hepatic impairment, and the recommended dose for patients with severe hepatic impairment has not been established.

Storage and Handling

• Bottle of 90 counts (100 mg)
• Bottle of 30 counts (100 mg)

Store at 20°C to 25°C.