Synarel Nasal Solution

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-seryl-L-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 µL of the spray containing approximately 200 µg 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 Nasal Solution »


Synarel Nasal Solution Patient Information Including Side Effects

Brand Names: Synarel

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

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

What is nafarelin nasal (Synarel Nasal Solution)?

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 Nasal Solution)?

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 Nasal Solution)?

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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