Zoladex 10.8 mg

DRUG DESCRIPTION

ZOLADEX® (goserelin acetate implant), contains a potent synthetic decapeptide analogue of luteinizing hormone-releasing hormone (LHRH), also known as a gonadotropin releasing hormone (GnRH) agonist analogue. Goserelin acetate is chemically described as an acetate salt of [D-Ser(But)6,Azgly10]LHRH. Its chemical structure is pyro-Glu-His-Trp-Ser-Tyr-D-Ser(But)-Leu-Arg-Pro-Azgly-NH2 acetate [C59H84N18O14 • (C2H4O2)x where x = 1 to 2.4].

Goserelin acetate is an off-white powder with a molecular weight of 1269 Daltons (free base). It is freely soluble in glacial acetic acid. It is soluble in water, 0.1M hydrochloric acid, 0.1M sodium hydroxide, dimethylformamide and dimethyl sulfoxide. Goserelin acetate is practically insoluble in acetone, chloroform and ether.

ZOLADEX 10.8 mg (goserelin acetate implant) implant is supplied as a sterile, biodegradable product containing goserelin acetate equivalent to 10.8 mg of goserelin. ZOLADEX is designed for subcutaneous implantation with continuous release over a 12-week period. Goserelin acetate is dispersed in a matrix of D,L-lactic and glycolic acids copolymer (12.82-14.76 mg/dose) containing less than 2% acetic acid and up to 10% goserelin-related substances and presented as a sterile, white to cream colored 1.5 mm diameter cylinder, preloaded in a special single-use syringe with a 14-gauge x 36 +/- 0.5 mm siliconized needle with protective needle sleeve (SafeSystem™ Syringe) in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule.

Studies of the D,L-lactic and glycolic acids copolymer have indicated that it is completely biodegradable and has no demonstrable antigenic potential.

ZOLADEX is also supplied as a sterile, biodegradable product containing goserelin acetate equivalent to 3.6 mg of goserelin designed for administration every 28 days.

What are the possible side effects of goserelin (Zoladex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • back pain, severe numbness or tingling in your legs or feet;
  • muscle weakness, problems with balance or coordination;
  • loss of bladder or bowel control;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • feeling like you...

Read All Potential Side Effects and See Pictures of Zoladex 10.8 mg »

What are the precautions when taking goserelin acetate implant (Zoladex 10.8 mg)?

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., triptorelin); 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: unexplained abnormal vaginal bleeding, diabetes, long-term alcohol use, smoking, personal or family history of bone loss (osteoporosis), high cholesterol/triglyceride levels, stroke, urinary blockage problem (in men), spinal cord problem (in men).

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels...

Read All Potential Precautions of Zoladex 10.8 mg »


Zoladex 10.8 mg Consumer (continued)

SIDE EFFECTS: Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, hair loss, or mental/mood changes (such as depression, mood swings, hallucinations) may occur. Pain, bruising, bleeding, redness, or swelling at the injection site may also occur. In women, vaginal dryness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal burning/pain (in women), pain during sex (in women), breast pain/tenderness, new/worsening bone pain, new broken bone, burning feeling in feet/toes, swelling of the ankles/feet, unusual tiredness, change in the amount of urine.

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, trouble breathing, confusion, vision changes, slurred speech, weakness on one side of the body.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.

In men using this medication for prostate cancer, a rare but very serious urinary blockage problem or spinal cord problem (compression) can occur, especially during the first month of treatment. Tell your doctor immediately if you experience any of the following serious side effects: severe back pain, numbness/tingling/weakness of the arms/legs, inability to move, painful/difficult urination, blood in the urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., triptorelin); 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: unexplained abnormal vaginal bleeding, diabetes, long-term alcohol use, smoking, personal or family history of bone loss (osteoporosis), high cholesterol/triglyceride levels, stroke, urinary blockage problem (in men), spinal cord problem (in men).

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Goserelin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using goserelin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using goserelin safely.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age must make sure they are not pregnant before starting this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. For women, this medication should stop the release of an egg (ovulation) and your periods, but this should not be used as a reliable method of birth control. It is recommended that men and women using this medication use 2 effective forms of nonhormonal birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Continue using effective birth control until the return of the woman's period or for at least 12 weeks after stopping this medication.

It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Zoladex 10.8 mg Patient Information Including Side Effects

Brand Names: Zoladex

Generic Name: goserelin (Pronunciation: GOE se REL in)

  • What is goserelin (Zoladex 10.8 mg)?
  • What are the possible side effects of goserelin (Zoladex 10.8 mg)?
  • What is the most important information I should know about goserelin (Zoladex 10.8 mg)?
  • What should I discuss with my healthcare provider before receiving goserelin (Zoladex 10.8 mg)?
  • How is goserelin given (Zoladex 10.8 mg)?
  • What happens if I miss a dose (Zoladex 10.8 mg)?
  • What happens if I overdose (Zoladex 10.8 mg)?
  • What should I avoid while receiving goserelin (Zoladex 10.8 mg)?
  • What other drugs will affect goserelin (Zoladex 10.8 mg)?
  • Where can I get more information?

What is goserelin (Zoladex 10.8 mg)?

Goserelin is a man-made form of a hormone that regulates many processes in the body. Goserelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Goserelin is used in men to treat symptoms of prostate cancer, and in women to treat breast cancer or endometriosis. Goserelin is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding).

If you are receiving goserelin to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Goserelin treats only the symptoms of prostate cancer but does not treat the cancer itself.

Goserelin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of goserelin (Zoladex 10.8 mg)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • back pain, severe numbness or tingling in your legs or feet;
  • muscle weakness, problems with balance or coordination;
  • loss of bladder or bowel control;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • feeling like you might pass out;
  • trouble breathing;
  • pale skin, easy bruising;
  • chest pain or heavy feeling, changes in heart rate; or
  • nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless.

Less serious side effects may include:

  • hot flashes, sweating, headache, dizziness;
  • mood changes, vaginal dryness, increased or decreased interest in sex;
  • impotence, fewer erections than normal;
  • breast swelling or tenderness;
  • bone pain;
  • nausea, vomiting, diarrhea, constipation;
  • loss of appetite, nausea, or diarrhea;
  • sleep problems (insomnia); or
  • acne, mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about goserelin (Zoladex 10.8 mg)?

This medication can harm an unborn baby or cause birth defects and should not be used during pregnancy. Use effective non-hormonal (barrier) birth control during treatment and for at least 12 weeks after treatment ends. Tell your doctor right away if you become pregnant during treatment.

Do not use goserelin if you are pregnant or breast-feeding.

You should not use this medication if you are allergic to goserelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon). Do not use goserelin if you are pregnant or breast-feeding.

Before you receive goserelin, tell your doctor if you have osteoporosis, diabetes, urination problems, a condition affecting your spine, or if you have abnormal bleeding that your doctor has not checked.

Goserelin can decrease bone mineral density, which may increase your risk of developing osteoporosis. This risk may be greater if you smoke, drink alcohol frequently, have a family history of osteoporosis, or use certain drugs such as seizure medications or steroids. Talk to your doctor about your individual risk of bone loss.

Call your doctor at once if you have a serious side effect such as severe numbness or tingling in your legs or feet, muscle weakness, problems with balance or coordination, loss of bladder or bowel control, urinating more or less than usual, pain or burning when you urinate, feeling like you might pass out, pale skin, easy bruising, trouble breathing, chest pain or heavy feeling, or changes in heart rate.

If you are using goserelin to treat prostate cancer, use any other medications your doctor has prescribed to best treat your condition. Goserelin treats only the symptoms of prostate cancer but does not treat the cancer itself.

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