Xtandi 40mg capsules, containing enzalutamide, are a hormonal therapy prescribed for advanced prostate cancer treatment, primarily indicated for patients with metastatic castration-resistant prostate cancer. The usual dosage is 160mg, taken with or without food, and there are numerous warnings regarding drug interactions, contraindications, and potential adverse effects, including serious conditions like seizures and cardiovascular risks. Patients should not self-medicate and must follow medical guidance for dosing, missed doses, and monitoring for adverse reactions.

1. XTANDI DOSING CONDITIONS AND ADMINISTRATION
MECHANISM
PHARMACOKINETICS
WARNING AND PRECAUTIONS
MISSED DOSE
DRUG INTERACTION
CONTRAINDICATION
OVER DOSAGE
XTANDI SIDE EFFECTS
Xtandi 40mg Capsules

2.  Xtandi 40mg is a hormonal therapy used for advanced prostate
cancer treatment, like for 0men who are all affected with prostate
carcinoma in metastatic stage.
 These are majorly indicated for prostate carcinoma, which contains
Enzalutamide, as an active component considered as non steroidal
anti-androgen medication. It is involved in association with castration
in the therapy of metastatic or long lasting castration resistant
prostate cancer. It is a prescribing medicine, the main ingredient
which is used as enzalutamide, only prescribed by medical
oncologist.

3.  The usual prescribed dosage of Xtandi is 160mg as a single dose by taking
with or without food. Xtandi 40mg is available in the strength of 40mg;
four Capsules of Xtandi 40mg should be administered at a same time.
 Xtandi 40mg Capsule should not crush, not chew taken with glass of
water. Xtandi Dosing adjustment: In patients with ≥ grade III
toxicity: Xtandi 40mg therapy should be refuse for one week or the
symptoms should be reduced to grade II, then restart with same dose or
decreased to 80mg or 120mg Strong CYP2C8 inhibitors
Xtandi 40mg Capsule

4.  While combining with Xtandi 40mg Capsule, the dosage should be
modified by reducing to 80mg as a single dose or avoid this combination.
Strong CYP3A4 inducers: Co administration of Xtandi 40mg with Strong
CYP3A4 inducers, xtandi dosage increased up to 240mg or stop this
combination.

5.  An androgen which is a male hormone is used to develop prostate
carcinoma. One of the major hormone secreted by testes and
adrenal glands is known as testosterone.
 Xtandi 40mg containing Enzalutamide will interfere with
testosterone production, causes tumor cell growth depletion. It
interfere with androgen receptor signaling transduction and leads
to cancer cellulysis

6. Absorption :
 After receiving 160mg of Xtandi 40mg for mCRPC, from median time to attain peak
plasma concentration time at 1 hour (variation with 0.5 to 3 hours). The steady
state level of Xtandi 40mg Capsule is accomplished by day 28 Food does not cause
any alteration in absorption of Xtandi 40mg Capsules.
Distribution :
 Volume of distribution 110L High plasma protein bounding capacity of Xtandi
40mg Capsules is occurs as 97% to 98%
Metabolism:
 Two most prominent cytochrome isoenzymes are involved in metabolism of Xtandi
40mg Capsule. There are two isoenzymes i.e CYP2C8 & CYP3A4; in which CYP2C8 is
vital for production of N-desmethyl Enzalutamide which is an active metabolite of
Enzalutamide.
Excretion :
 Xtandi 40mg Capsule undergoes excretion by hepatic metabolism .
Elimination :
 71% in urine; 14% in feces The terminal half life period of Xtandi 40mg Capsule.
Capsules is 5.8 days (range at 2.8 to 10.2 days); N-desmethyl Enzalutamide has half
life period of relatively 7.8 to 8.6 days.

7.  During the treatment with Xtandi 40mg Capsules, patient may suffer with
some adverse effects like; Posterior reversible encephalopathy syndrome
Seizures In PRES, some neurological disorders occur in patients.
 The condition can recovered by providing safety measures or discontinue
the therapy as soon as possible. PRES is recognized by using MRI In
seizures, Before starting the treatment patient must counsel about this
adverse reaction and Stop the therapy if possible.
 Spermatogenesis occurs that may prohibit the male fertility leads to hypo
spermatogenesis. In androgen decline the treatment, may have increase
exposure of cardiovascular disease like worsening hypertension.
Xtandi 40mg Capsule

8. Pregnancy :
 Pregnancy category of Xtandi 40mg Capsule is D Xtandi40mg is
contraindicated to pregnancy; it may cause fetal harm even to
death.
Lactation :
 Breast feeding is not suggested, Xtandi 40mg is contraindicated in
lactation
MISSED DOSE
 Xtandi 40mg is a chemical drug, used in prostate cancer. Xtandi
40mg Capsule should not be self medicated, used by the patients
only after getting advice from the medical oncologist.
 If a single dose missed by patient, then must consult with the
physician and follow the instructions as per the guidance of
medical adviser, the missed dose should be taken within a time or
avoid the missed dose and follow the regular schedule.

9.  Xtandi 40mg interact with some drugs like Xtandi 40mg drug combined
with CYP2C8 strong inhibitors, causes elevation of plasma concentration
time curve of Enzalutamide and its active metabolite.
 So avoid this combination, otherwise dosage of Xtandi 40mg should be
reduced to 80mg. Xtandi with CYP2C8 strong inducers causes variation
in plasma exposure of Xtandi, to minimize this problem to avoid this
concomitant. Co administration of Xtandi Capsules with strong inhibitors
or CYP3A4, leads to elevate the AUC of Enzalutamide and its metabolite.
CYP3A4 strong inducers example like; phenytoin, Phenobarbital,
carbamazepine etc combines with Xtandi40mg .
 Capsules causes depletes the plasma exposure of Xtandi. Moderate
CYP3A4 inducers like Bosentan, efavirenz, modafinil, st Johns wort
causes decreasing the plasma concentration of Xtandi Capsule. Xtandi
40mg Capsules are strong CYP3A4 inducers and moderate CYP2C8 &
CYP2C19. CYP3A4 strong inducers like Midazolam, CYP2C8 inducers like
warfarin, & CYP2C19 inducers like Omeprazole with Xtandi 40mg causes
reducing the plasma risk of Midazolam, warfarin & Omeprazole.

10. CONTRAINDICATION
 Xtandi 40mg Capsules are contraindicated to pregnancy condition,
which may cause fetal harm leads to death. An Anaphylactic
reaction happens, if patients are contraindicated to the ingredient
present in Xtandi Capsules.
OVER DOSAGE
 In the case of over dosage of Xtandi Capsules, causes severe
seizures. If occurring of over dosage , immediately discontinue the
treatment and maintain the safety measures. In dose acceleration
study at ≤ 240mg daily the condition seizure does not occur. If the
dose of 360mg, 480mg & 600mg at high risk will causes Seizures

11.  Some side effects during the therapy using with Xtandi; Back
pain, Arthralgia, Muscular weakness, pain, Diarrhea,
Hypertension & hot flush, Dizziness, headache, Asthenia
conditions, Peripheral edema, Spinal cord compression,
paresthesia, Mental impairment, Hypesthesia, Respiratory tract
infections, Hematuria, Pollakiuria, Dry skin, Pruritus,
Neutropenia, Thrombocytopenia, Increasing bilirubin level,
Epistaxis, Infections like sepsis, Fractures, joint injury, and
hematomas (Fall associated injuries). Hallucinations.

12.  Phone : 9987711567
 Email : applepharmaceutical@gmail.com
 Email : info@myapplepharma.com
 Website : https://myapplepharma.com/enzalutamide-40mg.php
https://myapplepharma.com/enzalutamide.php