The Savella® Pregnancy Registry

Address:

The Savella® Pregnancy Registry
Kendle International Inc.
1011 Ashes Drive
Wilmington, NC 28405

Email: registries@kendle.com

Toll-free Phone Number:

U.S. 1-877-643-3010

Toll-free Fax Number:

U.S.1-800-800-1052

For answers to specific questions about Savella, please contact Forest by dialing 1-800-678-1605.

Savella (milnacipran HCl) is indicated for the management of fibromyalgia in adults. Savella is available by prescription only.

Important Risk Information About Savella

Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Patients on antidepressants and their families or caregivers should watch for new or worsening symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your Health Care Provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever there is a change in dose, either increase or decrease. Savella is not approved for use in treating depression.

Questions about Savella

Who should NOT take Savella?

Do not take Savella if you:

Are taking or have recently taken a type of drug called a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcyprominesulfate).

Have uncontrolled narrow-angle glaucoma (an eye disease).

What should I tell my Health Care Provider before taking Savella?

Before starting Savella, tell your Health Care Provider about all of your medical conditions, including if you have:

Hypertension (high blood pressure), tachyarrhythmia (fast heart rate), or other cardiac diseases

Liver problems or a history of substantial alcohol use

Kidney problems, including dysuria (painful urination)

History of mania or seizure disorders

Bleeding disorders

Glaucoma

Also, to avoid a potentially serious or life-threatening condition, tell your Health Care Provider if you are taking, or planning to take, any prescription or over-the-counter medications, including:

Other SNRIs, (serotonin reuptake inhibitors), certain migraine or headache medications (triptans), or tryptophan

Medication prescribed for a psychiatric or neurological condition

NSAID pain relievers (such as ibuprofen or naproxen), aspirin, warfarin, or other blood thinners

Diuretics

Tell your Health Care Provider if you are pregnant, planning to become pregnant during therapy, or are breastfeeding.

What should I tell my Health Care Provider before taking Savella?

Your blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella.

You should not operate machinery or drive until you are reasonably certain that Savella treatment does not affect your ability to engage in such activities. Avoid drinking alcohol while taking Savella.

Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and/or blood pressure. These may be signs of a rare but serious side effect.

Talk with your Health Care Provider before stopping Savella or changing your dose. Withdrawal symptoms can occur, particularly when discontinuation is abrupt.

What should I tell my Health Care Provider before taking Savella?

The most common side effect associated with Savella treatment is nausea. In clinical trials, patients experiencing nausea described it as mild to moderate. Other common side effects were headache, constipation, dizziness, insomnia, hot flashes, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension.

This is not a complete list of side effects.