Pronunciation:

kor-ee-ON-ok goe-nad-oh-TROE-pin

Brand Names:

• Chorex
• Novarel
• Ovidrel
• Pregnyl
• Profasi
• Chorionic Gonadotropin

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Gonadotropin

Uses of This Medicine:

Chorionic gonadotropin injection is a hormone used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation. It is also used to help men with low sperm counts produce more sperms and used when testicles have not dropped down in the scrotum which is caused by a pituitary gland problem.

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 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.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of chorionic gonadotropin injection in children. However, children are more likely to develop early puberty, which may require caution or adjustments in the dose in patients receiving this medicine.

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of chorionic gonadotropin injection in the elderly.

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.

Other 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.

Other interactions—

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:

• Abnormal or unusual vaginal bleeding or
• Adrenal gland problems, uncontrolled or
• High levels of follicle stimulating hormone (FSH) or
• Organ defects or
• Pituitary gland problems, uncontrolled or
• Thyroid gland problems, uncontrolled or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—Should not be used in patients with these conditions.

• Blood clots (eg, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Hypertension (high blood pressure) or
• Lung or breathing problems or
• Migraine or
• Ovary problems, history of or
• Seizures or
• Stroke, history of or
• Surgery, history of—Use with caution. May make these conditions worse.

• 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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, semen testing, and ultrasound examinations are needed to check for any unwanted effects caused by this medicine.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

This medicine may cause ovarian hyperstimulation syndrome (OHSS), which can be life-threatening. Check with your doctor right away if you have bloating, diarrhea, severe nausea, stomach pain, rapid weight gain, or vomiting.

This medicine may cause serious lung problems (eg, atelectasis, acute respiratory distress syndrome, or asthma). Check with your doctor right away if you have blue lips, fingernails, or skin, chest tightness, coughing, difficulty or fast breathing, fever, rapid heartbeat, or trouble breathing.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain or tightness, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.

This medicine may increase your risk of having ovarian cancer if you received it more than one time to get pregnant. Talk to your doctor about this risk.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you know how to do this. Carefully follow your doctor's instructions.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

For females only

More common

Bloating (mild)

stomach or pelvic pain

Less common or rare

Bloating (moderate to severe)

decreased amount of urine

diarrhea

feeling of indigestion

nausea

pelvic pain (severe)

rapid weight gain

stomach pain, severe

swelling of feet or lower legs

trouble breathing

vomiting

For boys only

Less common

Acne

enlargement of penis and testes

growth of pubic hair

increase in height (rapid)

Incidence not known

Chest tightness

flushing of the skin

hives or welts

itching of the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

pain in chest, groin, or legs, especially in the calves

redness of the skin

severe, sudden headache

skin rash

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

unusually warm skin

vision changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

discouragement

enlargement of breasts

feeling sad or empty

headache

irritability

lack of appetite

loss of interest or pleasure

trouble concentrating

trouble sleeping

tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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