Pregnyl

Pregnyl is part of the drug class:

• Gonadotropins

Serious side effects have been reported with Pregnyl including the following:

• Life-threatening allergic reactions. Discontinue using Pregnyl and get medical attention immediately if you experience facial, lip, tongue, throat swelling and/or difficulty breathing.
• Hyperstimulation and/or enlargement of the ovaries. Discontinue using Pregnyl and get medical attention immediately if you experience abnormal severe abdominal pain.
• Full body swelling. Discontinue using Pregnyl and get medical attention immediately if you experience abnormal swelling of your extremities and/or abdomen.
• Fluid in the lungs. Discontinue using Pregnyl and get medical attention immediately if you experience sudden difficultly breathing.
• Early-onset puberty. Discontinue using Pregnyl and get medical attention immediately if you or your child experiences symptoms of early-onset puberty including increased hair growth and thickening, deepening of the voice, acne, early breast development, and/or rapid height growth.

Do not take Pregnyl if you:

• Are allergic to Pregnyl or to any of its ingredients
• Have early-onset puberty
• Have prostate cancer
• Have other cancers that are stimulated by androgens

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pregnyl falls into category X. It has been shown that women taking Pregnyl during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Take Pregnyl exactly as prescribed.

This medication is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional typically three times per week.

If you miss a dose, receive the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and receive your next dose at the regular time. Do not receive two doses of Pregnyl at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Pregnyl to promote descent of the testicles in young boys is:

1. 4000 units 3 times weekly for 3 weeks
2. Then, 5000 units every second day for 4 injections
3. Then, 15 injections for 500 to 1000 units over a period of 6 weeks
4. Then, 500 units 3 times weekly for 4 to 6 weeks.
5. If this course of treatment is not successful, another series is begun 1 month later, giving 1000 units per injection

The recommended dose of Pregnyl to promote hormone production in men is:

1. 500 to 1000 units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks
2. Then, 4000 units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 units 3 times weekly for an additional 3 months

The recommended dose range of Pregnyl to promote ovulation and pregnancy in women is:

• 5000 to 10,000 USP units given once

Chorionic gonadotropin is a drug whose actions are almost the same as those of luteinizing hormone (LH), which is produced by the pituitary gland. It is a hormone also normally produced by the placenta in pregnancy. Chorionic gonadotropin has different uses for females and males.

In females, chorionic gonadotropin is used to help conception occur. It is usually given in combination with other drugs such as menotropins and urofollitropin. Many women being treated with these drugs usually have already tried clomiphene alone (e.g., Serophene) and have not been able to conceive yet. Chorionic gonadotropin is also used in in vitro fertilization (IVF) programs.

In males, LH and chorionic gonadotropin stimulate the testes to produce male hormones such as testosterone. Testosterone causes the enlargement of the penis and testes and the growth of pubic and underarm hair. It also increases the production of sperm.

Although chorionic gonadotropin has been prescribed to help some patients lose weight, it should never be used this way. When used improperly, chorionic gonadotropin can cause serious problems.

Chorionic gonadotropin is to be administered only by or under the immediate supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Chorionic gonadotropin, when used for treating cryptorchidism (a birth defect where the testes remain inside the body), has caused the sexual organs of some male children to develop too rapidly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Migraine headaches—This medication may worsen these conditions.

• Cancer of the prostate or
• Precocious puberty (a condition that causes early puberty in boys before 9 years of age)—Increases in the amount of testosterone in the bloodstream may make these conditions worse.

• Cyst on ovary or
• Fibroid tumors of the uterus—Chorionic gonadotropin can cause further growth of cysts on the ovary or fibroid tumors of the uterus

• Unusual vaginal bleeding—Irregular vaginal bleeding is a sign that the endometrium is growing too much, of endometrial cancer, or of other hormone imbalances; the increases in estrogen production caused by ovulation can aggravate these problems of the endometrium. If other hormone imbalances are present, they should be treated before beginning ovulation induction

• If you have an allergy to chorionic gonadotropin (human) or any other part of Pregnyl (chorionic gonadotropin (human)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are a man and have prostate cancer.
• If you have ever had a cancer where hormones make it grow.
• If a child is using and has started puberty.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.

This is not a list of all drugs or health problems that interact with Pregnyl.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Pregnyl. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• Do not give Pregnyl to a newborn. It has benzyl alcohol.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Headache.
• Feeling tired or weak.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.