Novarel

Novarel is a prescription medication used to help with descent of the testicles in young boys, promote hormone production in men, and promote ovulation and pregnancy in women. Novarel belongs to a group of drugs called synthetic hormones, which work by helping to balance the levels of natural hormones in the body.

This medication comes in injectable form and is typically given three times per week directly into the muscle by a healthcare professional. 

Common side effects of Novarel include headache, irritability, and fatigue.

Novarel is a prescription medication used to promote descent of the testicles in young boys, promote hormone production in men, and promote ovulation and pregnancy in women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ferring Pharmaceuticals, Inc.

Serious side effects have been reported with Novarel. See the “Novarel Precautions” section.

Common side effects of Novarel include the following:

• headache
• rash
• irritability
• restlessness
• edema
• shortness of breath
• early-onset puberty
• swelling of breast tissue
• pain at the site of injection
• depression
• tiredness

This is not a complete list of Novarel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

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

• Hyperstimulation and/or enlargement of the ovaries. Discontinue using Novarel and get medical attention immediately if you experience abnormal severe abdominal pain.
• Life-threatening allergic reactions. Discontinue using Novarel and get medical attention immediately if you experience facial, lip, tongue, throat swelling and/or difficulty breathing.
• Early-onset puberty. Discontinue using Novarel 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.
• Fluid in the lungs. Discontinue using Novarel and get medical attention immediately if you experience sudden difficultly breathing.

Do not take Novarel if you:

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Novarel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Novarel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Novarel or to any of its ingredients
• have early-onset puberty
• have heart disease
• have kidney disease
• have asthma
• have epilepsy
• have prostate cancer or any other cancers that are stimulated by androgens
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• get migraine headaches

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Novarel falls into category X. It has been shown that women taking Novarel 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Novarel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Novarel.

Take Novarel 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 Novarel 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 Novarel 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 Novarel 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 Novarel to promote ovulation and pregnancy in women is:

• 5000 to 10,000 USP units given once

If Novarel is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep this and all medicines out of the reach of children.