Pregnyl

DRUG DESCRIPTION

Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence.

PREGNYL® (chorionic gonadotropin for injection, USP) is a highly purified pyrogen-free preparation obtained from the urine of pregnant females. It is standardized by a biological assay procedure. It is available for intramuscular injection in multiple dose vials containing 10,000 USP Units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium hydroxide and/or phosphoric acid. Each package also contains a 10 mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

What are the possible side effects of HCG (Novarel, Ovidrel, Pregnyl)?

Stop using HCG and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS...

Read All Potential Side Effects and See Pictures of Pregnyl »

What are the precautions when taking chorionic gonadotropin (Pregnyl)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: early puberty (in boys), male sex hormone-dependant cancer (e.g., prostate cancer) in boys.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., congestive heart failure), kidney disease, seizures, asthma, migraine headaches.

This medication must not be used during pregnancy. If you become...

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Pregnyl Consumer (continued)

SIDE EFFECTS: Headache, restlessness, tiredness, or pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, mental/mood changes (e.g., depression, irritability), signs of early puberty in boys (e.g., facial/pubic hair, voice change, acne), pain/swelling of the breast (in boys).

For women, when this medication is used with menotropins to treat infertility, also tell your doctor immediately if this unlikely but serious side effect occurs: abdominal pain/pressure/swelling.

For women, when this medication is used with menotropins to treat infertility, seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, slurred speech, weakness on one side of the body, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, shortness of breath.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: early puberty (in boys), male sex hormone-dependant cancer (e.g., prostate cancer) in boys.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., congestive heart failure), kidney disease, seizures, asthma, migraine headaches.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

When this medication is used in females with menotropins to treat infertility, it may cause multiple births (e.g., twins, triplets).

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Pregnyl Patient Information Including Side Effects

Brand Names: Novarel, Ovidrel, Pregnyl

Generic Name: human chorionic gonadotropin (HCG) (injectable) (Pronunciation: HUE man KORE ee ON ik goe NAD oh TRO pin)

  • What is HCG (Pregnyl)?
  • What are the possible side effects of HCG (Pregnyl)?
  • What is the most important information I should know about HCG (Pregnyl)?
  • What should I discuss with my healthcare provider before using HCG (Pregnyl)?
  • How should I use HCG (Pregnyl)?
  • What happens if I miss a dose (Pregnyl)?
  • What happens if I overdose (Pregnyl)?
  • What should I avoid while using HCG (Pregnyl)?
  • What other drugs will affect HCG (Pregnyl)?
  • Where can I get more information?

What is HCG (Pregnyl)?

Human chorionic gonadotropin (HCG) is a hormone that supports the normal development of an egg in a woman's ovary, and stimulates the release of the egg during ovulation.

HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men. HCG is also used in young boys when their testicles have not dropped down into the scrotum normally. This can be caused by a pituitary gland disorder.

HCG may also be used for other purposes not listed in this medication guide.

What are the possible side effects of HCG (Pregnyl)?

Stop using HCG and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pelvic pain;
  • swelling of the hands or legs;
  • stomach pain and swelling;
  • shortness of breath;
  • weight gain;
  • diarrhea;
  • nausea or vomiting; or
  • urinating less than normal.

This medication can cause early puberty in young boys. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth, and increased acne or sweating.

Less serious side effects may include:

  • headache;
  • feeling restless or irritable;
  • mild swelling or water weight gain;
  • depression;
  • breast tenderness or swelling; or
  • pain, swelling, or irritation where the injection is given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about HCG (Pregnyl)?

Human chorionic gonadotropin (HCG) is given as an injection under the skin or into a muscle. If you use this medicine at home, your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than normal.

HCG can cause early puberty in young boys. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth, and increased acne or sweating.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although HCG can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

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