Generic Name: milnacipran (mil-NA-si-pran)
Brand Name: Savella
Savella is similar to certain antidepressant medicines. Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Savella outweigh the risks.
Families and caregivers must closely watch patients who take Savella. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Savella is not approved for use in children or to treat depression.
Savella is used for:
Savella is a serotonin-norepinephrine reuptake inhibitor (SNRI). Exactly how Savella works to treat fibromyalgia is not known. It may work by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine).
Do NOT use Savella if:
- you are allergic to any ingredient in Savella
- you have uncontrolled narrow-angle glaucoma or end-stage kidney disease
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
- you are taking tryptophan, a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), or another SNRI (eg, duloxetine)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Savella:
Some medical conditions may interact with Savella. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (eg, aspirin, tartrazine)
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems (eg, heart failure, irregular heartbeat), recent heart attack, high blood pressure, bleeding problems, kidney problems, liver problems, urinary blockage or trouble urinating, enlarged prostate, or increased eye pressure (eg, glaucoma)
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you are being switched to Savella after taking another medicine called clomipramine
Some MEDICINES MAY INTERACT with Savella. Tell your health car provider if you are taking any other medicines, especially any of the following:
- 5-HT1 receptor agonists (eg, sumatriptan), lithium, MAOIs (eg, phenelzine), rasagiline, SNRIs (eg, venlafaxine), SSRIs (eg, fluoxetine, fluvoxamine), St. John's wort, tramadol, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDS) (eg, ibuprofen) because the risk of bleeding may be increased by Savella
- Digoxin, epinephrine, or norepinephrine because the risk of irregular heartbeat or blood pressure changes may be increased.
- Clonidine because its effectiveness may be decreased by Savella
This may not be a complete list of all interactions that may occur. Ask your health care provider if Savella may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Savella:
Use Savella as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Savella comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Savella refilled.
- Take Savella by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Take Savella on a regular schedule to get the most benefit from it. Taking Savella at the same time each day will help you remember to take it.
- Continue to take Savella even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Savella without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, nausea, nightmare, ringing in the ears, seizures, trouble sleeping, unusual tiredness, or vomiting. You will be closely monitored when you start Savella and whenever a change in dose is made.
- If you miss a dose of Savella, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Savella.
Important safety information:
- Savella may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Savella with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Savella.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Savella; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Savella may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Savella closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Savella. Your risk may be greater if you take Savella with certain other medicines (eg, SSRIs, "triptans"). Symptoms may include agitation; coma; confusion; excessive sweating; fast or irregular heartbeat; fever; hallucinations; nausea, vomiting, or diarrhea; tremor. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Savella. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- If your doctor tells you to stop taking Savella, you will need to wait for at least 5 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking Savella.
- If you are being switched to Savella after taking another medicine called clomipramine, you may have an increased risk for certain side effects (eg, dizziness or lightheadedness when standing, exaggerated sense of well-being). Contact your doctor if any of these symptoms occur.
- Lab tests, including blood pressure, heart rate, and liver function, may be performed while you use Savella. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Savella with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Caution is advised if using Savella in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
- Savella should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Savella may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Savella while you are pregnant. Savella is found in breast milk. If you are or will be breast-feeding while you use Savella, check with your doctor. Discuss any possible risks to your baby.
Do not suddenly stop taking Savella. Some conditions may become worse when the medicine is suddenly stopped. Your dose may need to be slowly lowered to avoid side effects.
Possible side effects of Savella:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased sexual desire or ability; dizziness; dry mouth; headache; hot flush; increased sweating; loss of appetite; nausea; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bloody or black, tarry stools; confusion; dark urine; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; memory problems; muscle pain or weakness; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, or diarrhea; severe or persistent trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; coma; confusion; dark urine; severe or persistent dizziness, drowsiness, or headache; trouble breathing; yellowing of the skin or eyes.Proper storage of Savella:
Store Savella at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Savella out of the reach of children and away from pets.
- If you have any questions about Savella, please talk with your doctor, pharmacist, or other health care provider.
- Savella is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Savella or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Savella. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Savella. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Savella.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.