Ovaxa Capsule

Introduction

Ovaxa Capsule 100 mg is a novel oral medication classified as a PARP (poly ADP-ribose polymerase) inhibitor. It is used primarily in the treatment of certain types of cancers, specifically ovarian cancer. Ovaxa Capsule 100 mg works by interfering with the repair of damaged DNA in cancer cells, thereby inhibiting their ability to repair and proliferate.

Uses

Ovaxa Capsule 100 mg is used for:

Treatment of advanced ovarian cancer: It is used in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. It can be used as maintenance therapy to prolong progression-free survival.
Treatment of other cancers: It is under investigation for use in other cancers that have BRCA mutations or other homologous recombination deficiencies, including breast cancer and prostate cancer.

Its use is generally based on genetic testing and the presence of specific biomarkers related to the cancer being treated.

Brand Name	Ovaxa
Type	Capsule
Weight	100 mg
Generic	Niraparib
Manufacturer	Jenphar Bangladesh Ltd.
Available in	English বাংলা

Mechanism of Action

Ovaxa Capsule 100 mg exerts its effects by inhibiting the PARP enzymes, which are involved in the repair of single-strand DNA breaks. By blocking PARP, niraparib prevents the repair of these breaks, leading to the accumulation of DNA damage and ultimately resulting in cell death, particularly in cancer cells with existing DNA repair deficiencies.

How Long Does It Take to Work?

The onset of clinical benefit from niraparib varies depending on individual patient factors and the type of cancer. For ovarian cancer, some patients may experience a clinical response within a few months of starting treatment. However, the full benefits and progression-free survival are typically assessed over longer periods, often 6 to 12 months, with regular monitoring and imaging studies.

Absorption

Ovaxa Capsule 100 mg is well absorbed from the gastrointestinal tract. The peak plasma concentration of niraparib occurs approximately 1 to 2 hours after oral administration. It has high oral bioavailability, but food intake does not significantly affect its absorption.

Route of Elimination

Ovaxa Capsule 100 mg is primarily metabolized in the liver. It undergoes oxidative metabolism and is excreted mainly in the feces (approximately 60%) and to a lesser extent in the urine. The drug is largely eliminated as metabolites, with only a small fraction excreted unchanged.

Dosage

The typical dosage of niraparib is:

300 mg taken orally once daily.

The dosage may vary based on individual patient factors, such as body weight and tolerability. Dosage adjustments may be necessary based on side effects and tolerability, as well as renal and hepatic function.

Administration

Ovaxa Capsule 100 mg is administered orally in the form of tablets. It should be taken at the same time each day with or without food. Patients should follow the prescribed dosing schedule and consult their healthcare provider if they miss a dose or have any issues with administration.

Side Effects

Common side effects of niraparib include:

Fatigue
nausea and vomiting
Decreased appetite
Myelosuppression: Anemia, thrombocytopenia, and neutropenia
Abdominal pain

Less common but serious side effects include blood clots, liver function abnormalities, and severe allergic reactions. Regular monitoring is necessary to manage and mitigate these side effects.

Toxicity

Toxicity from niraparib can manifest as severe myelosuppression, including anemia, thrombocytopenia, and neutropenia. Liver toxicity and gastrointestinal symptoms may also occur. In cases of severe toxicity, dose reductions or discontinuation may be required, and supportive care should be provided.

Precautions

Precautions should be taken in:

Patients with pre-existing hematological abnormalities, as niraparib may exacerbate conditions such as anemia or thrombocytopenia.
Patients with liver impairment, as dose adjustments may be needed.
Pregnant or breastfeeding women, due to potential risks to the fetus or infant.

Regular monitoring of blood counts and liver function is recommended during treatment.

Interaction

Ovaxa Capsule 100 mg may interact with:

CYP3A4 inhibitors and inducers: As niraparib is metabolized by CYP3A4, drugs that affect CYP3A4 activity may alter its levels. Dose adjustments may be needed for concomitant use of these drugs.
Other medications affecting blood cell counts: Concurrent use with drugs that impact bone marrow function may increase the risk of myelosuppression.

Inform healthcare providers of all medications being used to manage potential interactions.

Disease Interaction

Patients with:

Pre-existing hematologic disorders: Monitoring is required due to the risk of exacerbation of blood cell count abnormalities.
Liver disease: Dose adjustments may be necessary due to potential hepatic metabolism issues.

should be monitored closely to manage any potential disease interactions effectively.

Drug Interaction

Drug interactions with niraparib include:

Drugs that affect CYP3A4: May require dose adjustments of niraparib based on the interaction's impact on drug metabolism.
Other antineoplastic agents: May increase the risk of side effects or toxicities when used in combination with niraparib.

Always consult healthcare providers about potential drug interactions and manage them accordingly.

Food Interactions

Food does not significantly affect the absorption of niraparib. It can be taken with or without food. However, it is advisable to follow specific dietary recommendations provided by a healthcare provider to ensure consistent drug absorption and minimize gastrointestinal discomfort.

Pregnancy Use

Ovaxa Capsule 100 mg is classified as a Category D drug by the FDA, indicating that there is evidence of fetal risk. It should be avoided during pregnancy unless the benefits outweigh the risks. Women of childbearing potential should use effective contraception during treatment and consult their healthcare provider regarding pregnancy plans.

Lactation Use

The safety of niraparib during lactation has not been established. It is unknown if niraparib is excreted in breast milk. Due to potential risks to the nursing infant, breastfeeding is generally not recommended during treatment with niraparib. Consult a healthcare provider for guidance if breastfeeding.

Acute Overdose

Acute overdose of niraparib can lead to severe side effects, including exacerbated myelosuppression and potential organ toxicity. Immediate medical attention is necessary in the event of an overdose. Treatment typically involves supportive care and monitoring of blood counts and organ function.

Contraindication

Ovaxa Capsule 100 mg is contraindicated in individuals with:

Severe hypersensitivity to niraparib or any of its components.
Severe liver impairment that may preclude safe use of the drug.

Use of niraparib should be avoided in these cases to prevent adverse effects and ensure patient safety.

Use Direction

Follow the prescribed dosage and administration instructions provided by a healthcare provider. Take niraparib at the same time each day, with or without food. Regularly scheduled follow-up appointments and laboratory tests are important for monitoring treatment response and managing any side effects.

Storage Conditions

Store niraparib at room temperature, away from moisture and direct sunlight. Keep it in its original container and out of reach of children and pets. Follow any additional storage instructions provided by the manufacturer to maintain the drug's stability and effectiveness.

Volume of Distribution

The volume of distribution for niraparib is approximately 2.5 to 3.5 liters per kilogram. This indicates the extent to which the drug distributes into body tissues and fluids.

Half Life

The elimination half-life of niraparib is approximately 40 to 60 hours. This long half-life supports once-daily dosing and helps maintain therapeutic drug levels over time.

Clearance

The clearance of niraparib is primarily hepatic, with the drug being metabolized and excreted mainly in the feces. The clearance rate can be influenced by liver function and other factors, such as interactions with other medications.

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