Novarel (Subcutaneous, Intramuscular, Injection)

Chorionic gonadotropin injection is a hormone used as a fertility treatment to help women develop eggs when they have trouble getting 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 acts 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 females and males.

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

In males, LH and chorionic gonadotropin encourage the testes to produce male hormones, including testosterone. Testosterone leads to the growth of the penis and testes, as well as the development of pubic and underarm hair. It also boosts sperm production.

Although some patients have been prescribed chorionic gonadotropin for weight loss, it should never be used for this purpose. Misuse of chorionic gonadotropin 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 look 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. 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 (e.g., 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.

In deciding to use a medicine, you must consider the risks of taking it compared to the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Studies so far have not shown any specific problems in children that would limit the use of chorionic gonadotropin injection. However, children may develop early puberty more often, which could require caution or dose adjustments for patients receiving this medicine.

When used to treat cryptorchidism (a birth defect where the testes remain inside the body), chorionic gonadotropin may cause some male children's sexual organs to develop too quickly.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the use of chorionic gonadotropin injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using 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. Inform 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 around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. 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 causing 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 further growth of cysts on the ovary or fibroid tumors of the uterus.

Along with its necessary effects, this medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do occur, they may require medical attention.

Talk to your doctor or nurse right away if you notice any of the following side effects:

For females only

More common

• Mild bloating
• Stomach or pelvic pain

Less common or rare

• Moderate to severe bloating
• Decreased urine output
• Diarrhea
• Indigestion
• Nausea
• Severe pelvic pain
• Rapid weight gain
• Severe stomach pain
• Swelling in the feet or lower legs
• Difficulty breathing
• Vomiting

For boys only

Less common

• Acne
• Enlargement of the penis and testes
• Growth of pubic hair
• Rapid increase in height

Incidence not known

• Chest tightness
• Skin flushing
• Hives or welts
• Itching of the skin
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Pain in the chest, groin, or legs, especially in the calves
• Skin redness
• Severe, sudden headache
• Skin rash
• Slurred speech
• Sudden loss of coordination
• Sudden, severe weakness or numbness in an arm or leg
• Unusually warm skin
• Changes in vision

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have ways to help prevent or lessen some of these side effects. Talk to your healthcare professional if any of the following side effects persist, are bothersome, or if you have 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
• Feelings of discouragement
• Enlargement of breasts
• Feeling sad or empty
• Headaches
• Irritability
• Loss of appetite
• Loss of interest or pleasure
• Difficulty concentrating
• Trouble sleeping
• Fatigue

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

Contact your doctor for medical advice about side effects. You can 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

Find detailed information on biosimilars for this medication.

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