Synarel

DRUG DESCRIPTION

SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to the nasal mucosa. Nafarelin acetate, the active component of SYNAREL Nasal Solution, is a decapeptide with the chemical name: 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-serylL-tyrosyl-3-(2-naphthyl)-D-alanyl-L-leucyl-L-arginyl-L-prolyl-glycinamide acetate. Nafarelin acetate is a synthetic analog of the naturally occurring gonadotropin-releasing hormone (GnRH). Nafarelin acetate has the following chemical structure:

Synarel® (nafarelin acetate) Structural Formula Illustration

SYNAREL Nasal Solution contains nafarelin acetate (2 mg/mL, content expressed as nafarelin base) in a solution of benzalkonium chloride, glacial acetic acid, sodium hydroxide or hydrochloric acid (to adjust pH), sorbitol, and purified water.

After priming the pump unit for SYNAREL, each actuation of the unit delivers approximately 100 ?L of the spray containing approximately 200 ?g nafarelin base. The contents of one spray bottle are intended to deliver at least 60 sprays.

What are the possible side effects of nafarelin nasal (Synarel)?

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

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 serious side effects:

  • heavy or continued menstrual bleeding;
  • ...

Read All Potential Side Effects and See Pictures of Synarel »

What are the precautions when taking nafarelin acetate for central precocious puberty (Synarel)?

Before using nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (e.g., leuprolide); 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: unexplained abnormal vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels.

This medication...

Read All Potential Precautions of Synarel »


Synarel Consumer (continued)

SIDE EFFECTS: Nasal irritation, hot flashes, vaginal discharge, or mood swings may occur in children. Nasal irritation, hot flashes, headaches, mood swings, decreased sexual interest, muscle pain, vaginal dryness, acne, or decrease in breast size may occur in women. 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.

For women taking this medication, tell your doctor immediately if any of these unlikely but serious side effects occur: abdominal/lower back pain, bone pain, depression.

For women taking this medication, tell your doctor immediately if any of these rare but very serious side effects occur: fast/pounding heartbeat, numbness/tingling of arms/legs, eye pain.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.

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.

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 nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (e.g., leuprolide); 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: unexplained abnormal vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels.

This medication must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. Women should start this medication between days 2 and 4 of their period. Although periods and the release of eggs (ovulation) may stop while you are taking this drug, this should not be considered a reliable form of birth control. It is recommended that men and women using this medication use two effective non-hormonal forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Consult your doctor.

It is not known if this medication passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Synarel Patient Information Including Side Effects

Brand Names: Synarel

Generic Name: nafarelin nasal (Pronunciation: NAF a REL in)

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

What is nafarelin nasal (Synarel)?

Nafarelin nasal is a man-made form of a protein that is like a hormone in the body that helps regulate the menstrual cycle, fertility, and sexual development during puberty.

Nafarelin nasal is used to treat precocious puberty in both male and female children. It is also used to treat endometriosis in women who are 18 years of age or older.

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

What are the possible side effects of nafarelin nasal (Synarel)?

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

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 serious side effects:

  • heavy or continued menstrual bleeding;
  • chest pain, shortness of breath;
  • fast or irregular heartbeats; or
  • pelvic pain or swelling.

Less serious side effects may include:

  • mild itching or skin rash;
  • oily skin or acne, increased body odor;
  • dandruff;
  • changes in breast size;
  • increase in pubic hair growth;
  • nasal irritation or runny nose;
  • hot flashes;
  • mild headache, muscle pain;
  • mood swings;
  • white or brownish vaginal discharge;
  • light and occasional menstrual bleeding;
  • vaginal dryness; or
  • changes in sexual desire.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nafarelin nasal (Synarel)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective barrier form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use nafarelin nasal if you have ever had an allergic reaction to nafarelin or similar medicines such as gonadorelin (Factrel). Do not use nafarelin nasal if you are pregnant or breast-feeding, or if you have undiagnosed, abnormal vaginal bleeding.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

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