Enzumide Cap

Enzumide Cap

Enzalutamide Cap

Strength: 40mg

Pack Size: 1 x 28

Drug Class: Antineoplastic

Dosage and Administration:

Recommended Dosage
The recommended dosage of Enzumide is 160 mg administered orally once daily with or without food . Swallow capsules or tablets whole. Do not chew, dissolve, or open the capsules. Do not cut, crush, or chew the tablets.

Dosage Modifications For Adverse Reactions
If a patient experiences a ≥ Grade 3 or an intolerable adverse reaction, withhold XTANDI for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) if warranted [see WARNINGS AND PRECAUTIONS].

Dosage Modifications For Drug Interactions
Strong CYP2C8 Inhibitors
Avoid the coadministration of strong CYP2C8 inhibitors. If the coadministration of a strong CYP2C8 inhibitor cannot be avoided, reduce the XTANDI dosage to 80 mg once daily. If the coadministration of the strong inhibitor is discontinued, increase the XTANDI dosage to the dosage used prior to initiation of the strong CYP2C8 inhibitor [see CLINICAL PHARMACOLOGY].

Strong CYP3A4 Inducers
Avoid the coadministration of strong CYP3A4 inducers. If the coadministration of a strong CYP3A4 inducer cannot be avoided, increase the XTANDI dosage from 160 mg to 240 mg orally once daily. If the coadministration of the strong CYP3A4 inducer is discontinued, decrease the XTANDI dosage to the dosage used prior to initiation of the strong CYP3A4 inducer

Important Administration Instructions
Patients receiving Enzumide should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Cold Storage: no

Enzalutamide is an androgen receptor inhibitor. The chemical name is 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5- dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide.

The molecular weight is 464.44 and molecular formula is C21H16F4N4O2S. The structural formula is:

 

 

XTANDI® (enzalutamide) - Structural Formula - Illustration

 

Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water.

XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.

indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)

Usage-:

Enzalutamide is used to treat prostate cancer that has spread to other parts of the body in men and who have been helped by certain medical and surgical treatments that decrease testosterone levels.

The efficacy and safety of enzalutamide in patients with metastatic castration resistant prostate cancer who had received docetaxel and were using a gonadotropin-releasing hormone (GnRH) analogue. Enzalutamide was shown to be an effective and well-tolerated therapeutic option in patients with metastatic castration-resistant prostate cancer.

safety of enzalutamide in patients with metastatic castration resistant prostate cancer who had received docetaxel and were using a gonadotropin-releasing hormone (GnRH) analogue. Enzalutamide was shown to be an effective and well-tolerated therapeutic option in patients with metastatic castration-resistant prostate cancer.

Before taking enzalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressureseizures, risk factors for having seizures (such as brain injury, strokebrain tumor), heart disease (such as angina/chest painheart attack), diabeteshigh cholesterol or fats (triglycerides) in your blood, falls, broken bones.

Since this medication may rarely cause seizures in some people, ask your doctor if you should avoid activities where a sudden loss of consciousness may cause serious harm to you or others.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules or tablets.

This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Men who have a pregnant partner must use a condom during sexual activity during enzalutamide treatment and for 3 months after treatment has stopped. Men with a female partner of childbearing age who is not pregnant should use a condom and another form of birth control during enzalutamide treatment and for 3 months after treatment has stopped. Ask your doctor for more details. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away.

Consult your pharmacist or physician.