Niraparib Drug

Indications

Niraparib is an oral poly (ADP-ribose) polymerase (PARP) inhibitor used as a targeted therapy in the treatment of certain cancers. It is particularly significant in the management of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Niraparib is a medication classified as a PARP inhibitor.

 

Niraparib FDA Approval

The US Food and Drug Administration (FDA) granted it fast track designation to expedite its review. Tesaro, the company behind niraparib, submitted a new drug application in 2016. As a result, niraparib was approved in the United States on March 27, 2017, and subsequently received approval in the European Union on November 16, 2017.

 

Mechanism of Action

Niraparib is a medication used to treat certain types of cancer by interfering with the cancer cells’ ability to repair their DNA. Here’s a simple explanation of how it works:

DNA Damage and Repair: In our cells, DNA can get damaged by various factors. Normally, cells have repair mechanisms to fix this damage and keep the cell functioning properly.

Role of PARP Proteins: One of the key proteins involved in DNA repair is called PARP (Poly ADP-Ribose Polymerase). PARP detects DNA damage and helps to repair it, much like a mechanic fixing a broken car.

How does Niraparib Works: Niraparib is a type of drug known as a PARP inhibitor. It blocks the activity of PARP proteins, preventing them from repairing DNA damage in the cells.

Targeting Cancer Cells: Cancer cells, especially those with specific genetic mutations like BRCA mutations, rely heavily on PARP to repair their DNA and survive. When niraparib blocks PARP, these cancer cells accumulate DNA damage and eventually can’t survive.

Promoting Cancer Cell Death: By inhibiting PARP, niraparib causes cancer cells to become overwhelmed with DNA damage, leading to their death. This helps to control and reduce the growth of the tumor.

 

In summary, niraparib works by blocking the PARP proteins that cancer cells use to repair their DNA. Without the ability to repair their DNA, cancer cells accumulate damage and die, which helps in controlling the cancer.

 

Niraparib Side Effects

Common Side Effects:

• Fatigue
• Nausea
• Vomiting
• Loss of Appetite
• Constipation
• Diarrhea
• Abdominal Pain
• Anemia
• Thrombocytopenia
• Neutropenia
• Headache

Serious Side Effects:

1. High Blood Pressure (Hypertension): Niraparib can cause an increase in blood pressure, which should be monitored regularly.
2. Heart Issues: In rare cases, patients may experience heart problems, including palpitations or rapid heartbeat.
3. Bone Marrow Problems: Severe reductions in blood cell counts can occur, leading to increased risks of infections, anemia, and bleeding.
4. Secondary Cancers: Though rare, long-term use of PARP inhibitors like niraparib has been associated with an increased risk of developing certain types of secondary cancers, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

 

Dosages And Administration

The recommended Niraparib dose as monotherapy is 300 mg, which equates to three 100 mg capsules taken orally once daily. It is important for patients to take their dose of Niraparib at approximately the same time each day. Administering the dose at bedtime may help manage nausea.

Patients should begin treatment with Niraparib no later than 8 weeks after their most recent platinum-containing regimen. Treatment should continue until disease progression or the occurrence of unacceptable toxicity.

 

Administration

Oral use. Niraparib capsules should be swallowed whole with water. The capsules should not be chewed or crushed. Niraparib can be taken without regard to meals.

 

Missed a dose?

In the event of a missed dose, patients should take their next dose at the regularly scheduled time. If a patient vomits or misses a dose, they should not take an additional dose to make up for it.

 

Niraparib dose modification

Recommended dose modifications for adverse reactions

Starting dose – 300 mg/day (three 100 mg capsules)

First dose reduction – 200 mg/day (two 100 mg capsules)

Second dose reduction – 100 mg/day (one 100 mg capsule) 

If further dose reduction below 100 mg/day is required, discontinue Niraparib.

For further dose modification consult with your doctor.