Leuprolide Acetate Implant

What is this medicine?

LEUPROLIDE (loo PROE lide) is a man-made protein that acts like a natural hormone in the body. It decreases testosterone in men and decreases estrogen in women. In men, this medicine is used to treat advanced prostate cancer. In women, some forms of this medicine may be used to treat endometriosis, uterine fibroids, or other female hormone-related problems.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease or previous heart attack

• high blood pressure

• high cholesterol

• osteoporosis

• pain or difficulty passing urine

• spinal cord metastasis

• stroke

• tobacco smoker

• unusual vaginal bleeding (women)

• an unusual or allergic reaction to leuprolide, benzyl alcohol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or for injection under the skin. It is given by a health care professional in a hospital or clinic setting. The specific product will determine how it will be given to you. Make sure you understand which product you receive and how often you will receive it.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Call your doctor or health care professional if you are unable to keep an appointment.

Depot injections: Depot injections are given either once-monthly, every 12 weeks, every 16 weeks, or every 24 weeks depending on the product you are prescribed. The product you are prescribed will be based on if you are male or female, and your condition. Make sure you understand your product and dosing.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• herbal or dietary supplements, like black cohosh or DHEA

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• male hormones, like testosterone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. During the first weeks of treatment, your symptoms may get worse, but then will improve as you continue your treatment. You may get hot flashes, increased bone pain, increased difficulty passing urine, or an aggravation of nerve symptoms. Discuss these effects with your doctor or health care professional, some of them may improve with continued use of this medicine.

Female patients may experience a menstrual cycle or spotting during the first months of therapy with this medicine. If this continues, contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• depression or memory disorders

• pain in your legs or groin

• pain at site where injected or implanted

• severe headache

• swelling of the feet and legs

• visual changes

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• breast swelling or tenderness

• decrease in sex drive or performance

• diarrhea

• hot flashes

• loss of appetite

• muscle, joint, or bone pains

• nausea

• redness or irritation at site where injected or implanted

• skin problems or acne

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Leuprolide Acetate Solution for injection

What is this medicine?

LEUPROLIDE (loo PROE lide) is a man-made hormone. It is used to treat the symptoms of prostate cancer. This medicine may also be used to treat children with early onset of puberty. It may be used for other hormonal conditions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease or previous heart attack

• high blood pressure

• high cholesterol

• pain or difficulty passing urine

• spinal cord metastasis

• stroke

• tobacco smoker

• an unusual or allergic reaction to leuprolide, benzyl alcohol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or into a muscle. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• herbal or dietary supplements, like black cohosh or DHEA

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• male hormones, like testosterone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. During the first week, your symptoms may get worse, but then will improve as you continue your treatment. You may get hot flashes, increased bone pain, increased difficulty passing urine, or an aggravation of nerve symptoms. Discuss these effects with your doctor or health care professional, some of them may improve with continued use of this medicine.

Female patients may experience a menstrual cycle or spotting during the first 2 months of therapy with this medicine. If this continues, contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• depression or memory disorders

• pain in your legs or groin

• pain at site where injected

• severe headache

• swelling of the feet and legs

• visual changes

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• breast swelling or tenderness

• decrease in sex drive or performance

• diarrhea

• hot flashes

• loss of appetite

• muscle, joint, or bone pains

• nausea

• redness or irritation at site where injected

• skin problems or acne

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store below 25 degrees C (77 degrees F). Do not freeze. Protect from light. Do not use if it is not clear or if there are particles present. Throw away any unused medicine after the expiration date.

Leuprolide Acetate Suspension for injection

What is this medicine?

LEUPROLIDE (loo PROE lide) is a man-made protein that acts like a natural hormone in the body. It decreases testosterone in men and decreases estrogen in women. In men, this medicine is used to treat advanced prostate cancer. In women, some forms of this medicine may be used to treat endometriosis, uterine fibroids, or other female hormone-related problems.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease or previous heart attack

• high blood pressure

• high cholesterol

• osteoporosis

• pain or difficulty passing urine

• spinal cord metastasis

• stroke

• tobacco smoker

• unusual vaginal bleeding (women)

• an unusual or allergic reaction to leuprolide, benzyl alcohol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or for injection under the skin. It is given by a health care professional in a hospital or clinic setting. The specific product will determine how it will be given to you. Make sure you understand which product you receive and how often you will receive it.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Call your doctor or health care professional if you are unable to keep an appointment.

Depot injections: Depot injections are given either once-monthly, every 12 weeks, every 16 weeks, or every 24 weeks depending on the product you are prescribed. The product you are prescribed will be based on if you are male or female, and your condition. Make sure you understand your product and dosing.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• herbal or dietary supplements, like black cohosh or DHEA

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• male hormones, like testosterone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. During the first weeks of treatment, your symptoms may get worse, but then will improve as you continue your treatment. You may get hot flashes, increased bone pain, increased difficulty passing urine, or an aggravation of nerve symptoms. Discuss these effects with your doctor or health care professional, some of them may improve with continued use of this medicine.

Female patients may experience a menstrual cycle or spotting during the first months of therapy with this medicine. If this continues, contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• depression or memory disorders

• pain in your legs or groin

• pain at site where injected or implanted

• severe headache

• swelling of the feet and legs

• visual changes

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• breast swelling or tenderness

• decrease in sex drive or performance

• diarrhea

• hot flashes

• loss of appetite

• muscle, joint, or bone pains

• nausea

• redness or irritation at site where injected or implanted

• skin problems or acne

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.