Zoladex 10.8mg

Stage B2-C Prostatic Carcinoma

Zoladex 10.8mg is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with Zoladex 10.8mg and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Prostatic Carcinoma

Zoladex 10.8mg is indicated in the palliative treatment of advanced carcinoma of the prostate.

Endometriosis

Zoladex 10.8mg is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with Zoladex 10.8mg for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.

Endometrial Thinning

Zoladex 10.8mg is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.

Advanced Breast Cancer

Zoladex 10.8mg is indicated for use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women.

The estrogen and progesterone receptor values may help to predict whether Zoladex 10.8mg therapy is likely to be beneficial [seeDosage and Administration (2.6), Clinical Pharmacology (12.1), and Clinical Studies (14.5)].

The automatic safety feature of the syringe aids in the prevention of needlestick injury.

Zoladex 10.8mg is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:

• Cancer of the prostate in men
• Cancer of the breast in women if it develops before or around the time of menopause
• Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus, and
• Thinning of the lining of the uterus before surgery on the uterus.

When given regularly as an implant, Zoladex 10.8mg works every day to decrease the amount of estrogen and testosterone in the blood.

Reducing the amount of estrogen in the body is one way of treating endometriosis and cancer of the breast, and can help thin the uterus lining before surgery. Zoladex 10.8mg prevents the growth of tissue associated with endometriosis in adult women during treatment and for up to 6 months after treatment is discontinued.

Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

Suppressing estrogen can thin the bones or slow their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. This is why Zoladex 10.8mg is used only for up to 6 months in adult women treated for endometriosis.

Zoladex 10.8mg is to be given only by or under the supervision of your doctor.

Zoladex 10.8mg, at a dose of 3.6 mg, should be administered subcutaneously every 28 days into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician.

While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule.

Stage B2-C Prostatic Carcinoma

When Zoladex 10.8mg is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiation therapy. A treatment regimen using a Zoladex 10.8mg 3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by the Zoladex 10.8mg 10.8 mg depot, can be administered. Alternatively, four injections of 3.6 mg depot can be administered at 28-day intervals, two depots preceding and two during radiotherapy.

Prostatic Carcinoma

For the management of advanced prostate cancer, Zoladex 10.8mg is intended for long-term administration unless clinically inappropriate.

Endometriosis

For the management of endometriosis, the recommended duration of administration is 6 months.

Currently, there are no clinical data on the effect of treatment of benign gynecological conditions with Zoladex 10.8mg for periods in excess of 6 months.

Retreatment cannot be recommended for the management of endometriosis since safety data for retreatment are not available. If the symptoms of endometriosis recur after a course of therapy, and further treatment with Zoladex 10.8mg is contemplated, consideration should be given to monitoring bone mineral density. Clinical studies suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to Zoladex 10.8mg is effective in reducing the bone mineral loss which occurs with Zoladex 10.8mg alone without compromising the efficacy of Zoladex 10.8mg in relieving the symptoms of endometriosis. The addition of Hormone Replacement Therapy may also reduce the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism. The optimal drugs, dose and duration of treatment has not been established.

Endometrial Thinning

For use as an endometrial-thinning agent prior to endometrial ablation, the dosing recommendation is one or two depots (with each depot given four weeks apart). When one depot is administered, surgery should be performed at four weeks. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.

Breast Cancer

For the management of advanced breast cancer, Zoladex 10.8mg is intended for long-term administration unless clinically inappropriate.

Renal or Hepatic Impairment

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Administration Technique

The proper method of administration of Zoladex 10.8mg is described in the instructions that follow.

See also:
What is the most important information I should know about Zoladex 10.8mg?

Hypersensitivity

Anaphylactic reactions to Zoladex 10.8mg have been reported in the medical literature. Zoladex 10.8mg is contraindicated in those patients who have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in Zoladex 10.8mg.

Pregnancy

Zoladex 10.8mg is contraindicated during pregnancy unless Zoladex 10.8mg is being used for palliative treatment of advanced breast cancer. Zoladex 10.8mg can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormone changes that occur with Zoladex 10.8mg treatment.

Use Zoladex 10.8mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zoladex 10.8mg is usually given as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Zoladex 10.8mg, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Zoladex 10.8mg.

Use: Labeled Indications

Breast cancer, advanced (3.6 mg only): Palliative treatment of advanced breast cancer in pre- and perimenopausal women (estrogen and progesterone receptor values may help to predict if Zoladex 10.8mg is likely to be beneficial).

Endometrial thinning (3.6 mg only): Endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.

Endometriosis (3.6 mg only): Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy (Zoladex 10.8mg experience for endometriosis has been limited to women 18 years and older treated for 6 months).

Prostate cancer, advanced (3.6 mg or 10.8 mg): Palliative treatment of advanced carcinoma of the prostate.

Prostate cancer, stage B2 to C (3.6 mg or 10.8 mg): Management of locally confined stage T2b to T4 (stage B2 to C) prostate cancer (in combination with an antiandrogen [eg, flutamide]); begin Zoladex 10.8mg and antiandrogen therapy 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Off Label Uses

Breast cancer, advanced (second-line endocrine-based combination therapy)

Data from a large, randomized phase III study supports the use of Zoladex 10.8mg in pre- or perimenopausal women (in combination with palbociclib and fulvestrant) as second-line endocrine-based combination therapy in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with progression on prior endocrine therapy.

See also:
What other drugs will affect Zoladex 10.8mg?

Estrogen

Drug may cause initial transient increase in serum levels in women.

Hypercalcemia in patients with bone metastases

Drug may cause initial transient increase.

Testosterone

Drug may cause initial transient increases in serum levels in men.

See also:
What are the possible side effects of Zoladex 10.8mg?

Applies to Zoladex 10.8mg: subcutaneous implant

As well as its needed effects, Zoladex 10.8mg (the active ingredient contained in Zoladex 10.8mg) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking Zoladex 10.8mg, check with your doctor or nurse immediately:

For all adultsLess common:

• Fast or irregular heartbeat

• Bone, muscle, or joint pain
• changes in skin color of the face
• fainting
• fast or irregular breathing
• numbness or tingling of the hands or feet
• puffiness or swelling of the eyelids or around the eyes
• skin rash, hives, or itching
• sudden, severe decrease in blood pressure and collapse
• tightness in the chest
• troubled breathing

• Anxiety
• deepening of voice
• increased hair growth
• mental depression
• mood changes

• Pain in the chest
• pain in the groin or legs (especially in the calves of the legs)

Minor Side Effects

Some Zoladex 10.8mg side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

For all adultsMore common:

• Sudden sweating and feelings of warmth (also called hot flashes)

• Blurred vision
• burning, itching, redness, or swelling at the place of injection
• decreased interest in sexual intercourse
• dizziness
• headache
• nausea or vomiting
• swelling and increased tenderness of the breasts
• swelling of the feet or lower legs
• trouble sleeping
• weight gain

• Light, irregular vaginal bleeding
• stopping of menstrual periods

• Burning, dryness, or itching of the vagina
• pelvic pain

• Bone pain
• constipation
• decreased size of the testicles
• inability to have or keep an erection

Zoladex 10.8mg is a synthetic hormone. In men, it stops the production of the hormone testosterone, which may stimulate the growth of cancer cells. In women, Zoladex 10.8mg decreases the production of the hormone estradiol (which may stimulate the growth of cancer cells) to levels similar to a postmenopausal state. When the medication is stopped, hormone levels return to normal.