Profasi (Subcutaneous, Intramuscular, Injection)

Chorionic gonadotropin injection is a hormone used as a fertility treatment to help develop eggs in women who have difficulty becoming pregnant due to ovulation issues. It is also used to assist men with low sperm counts in producing more sperm and is used when testicles have not descended into the scrotum due to a pituitary gland issue.

Chorionic gonadotropin is a medication that works similarly to luteinizing hormone (LH), which is made by the pituitary gland. It is also a hormone normally produced by the placenta during pregnancy. Chorionic gonadotropin has different roles for women and men.

In women, chorionic gonadotropin helps with conception. It is usually given along with other medications like menotropins and urofollitropin. Many women receiving these treatments have already tried clomiphene alone without success in becoming pregnant. Chorionic gonadotropin is also used in in-vitro fertilization (IVF) programs.

In men, LH and chorionic gonadotropin stimulate the testes to produce male hormones such as testosterone. Testosterone causes the penis and testes to grow and leads to the development of pubic and underarm hair. It also boosts sperm production.

While chorionic gonadotropin has been prescribed for some patients trying to lose weight, it should never be used for this purpose. Using chorionic gonadotropin incorrectly can lead to serious problems.

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

It is very important that your doctor checks your progress at regular visits to ensure that the medicine is working properly and to monitor for any 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 a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you experience 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. Contact your doctor immediately if you have bloating, diarrhea, severe nausea, stomach pain, rapid weight gain, or vomiting.

This medicine may cause serious lung problems (e.g., atelectasis, acute respiratory distress syndrome, or asthma). Contact 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 immediately if you have chest pain or tightness, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, sudden difficulty 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. Discuss this possibility with your doctor before you start using this medicine.

This medicine may increase your risk of having ovarian cancer if you have received it more than once 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 you know how to do this. Carefully follow your doctor's instructions.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it provides. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems that would limit the use of chorionic gonadotropin injection in children. However, children might develop early puberty, which could require caution or dose adjustments when using this medicine.

Chorionic gonadotropin, when used to treat cryptorchidism (a condition where the testes stay inside the body), has caused some male children's sexual organs to develop too quickly.

Geriatric

Current studies have not indicated any specific problems that would limit the use of chorionic gonadotropin injection in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose or take other precautions. 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 taken at the same time as food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Make sure to tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Uncontrolled adrenal gland problems or
• High levels of follicle stimulating hormone (FSH) or
• Organ defects or
• Uncontrolled pituitary gland problems or
• Uncontrolled thyroid gland problems or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—This medicine should not be used in patients with these conditions.

• Blood clots (e.g., pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Hypertension (high blood pressure) or
• Lung or breathing problems or
• Migraine or
• History of ovary problems or
• Seizures or
• History of stroke or
• History of surgery—Use with caution. This medicine may worsen these conditions.

• Prostate cancer or
• Precocious puberty (a condition that causes early puberty in boys before age 9)—Increases in testosterone levels in the bloodstream may worsen these conditions.

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

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.

In the U.S.

• Chorex
• Novarel
• Ovidrel
• Pregnyl
• Profasi

In Canada

• Chorionic Gonadotropin

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin

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