SAVELLA® (milnacipran HCl) is a prescription medication used to manage fibromyalgia. It is not known if SAVELLA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
SAVELLA may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following symptoms:
- Suicidal thoughts or actions:
- SAVELLA and antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice:
- New or sudden changes in mood, behavior, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when SAVELLA is started or when the dose is changed.
- Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
- Call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry, or irritable; trouble sleeping (insomnia); an increase in activity or talking more than what is normal for you; or other unusual changes in behavior or mood.
- Serotonin syndrome. This condition can be life-threatening. Symptoms may include: agitation, hallucinations, coma, or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); sweating or fever; diarrhea; muscle rigidity; dizziness; and tremor. Symptoms such as racing heartbeat, high or low blood pressure, nausea, vomiting, and flushing are common with SAVELLA.
- Increase in blood pressure or heart rate. Check your blood pressure and heart rate before starting and throughout SAVELLA treatment. Before starting SAVELLA, tell your doctor if you have high blood pressure or problems with your heart or blood vessels (cardiovascular disease).
- Seizures or convulsions.
- Liver problems. Itching, right upper-belly pain, dark urine, yellow skin or eyes, enlarged liver, increased liver enzymes, or unexplained flu-like symptoms may be signs of life-threatening liver problems.
- Low salt levels in the blood. Headache, weakness, confusion, problems concentrating, or memory problems may be signs of low salt levels in the blood. Elderly people may be at greater risk.
- Abnormal bleeding. SAVELLA and other similar medicines (antidepressants that impact serotonin) may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, a nonsteroidal anti-inflammatory drug (NSAID), or aspirin.
- Manic episodes. Manic episodes may include greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excess happiness or irritability, and talking more or faster.
- Problems with urination. These may include decreased urine flow or inability to pass urine.
- Visual problems. Problems may include eye pain, changes in vision, and swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
- Sexual problems. Taking SAVELLA may cause sexual problems. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment.
Do not stop SAVELLA without first talking to your healthcare provider. Stopping SAVELLA too quickly may cause serious symptoms, including:
- anxiety, irritability, or confusion
- feeling tired or problems sleeping
- headache, dizziness, or seizures
- electric shock-like sensations or ringing in ears
SAVELLA is not for everyone. Do not take SAVELLA if you:
- Take a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid. Taking SAVELLA close in time to these medications can cause serious or even life-threatening side effects. Do not start SAVELLA within 14 days of stopping an MAOI medication. Do not start an MAOI medication within 5 days of stopping SAVELLA. If you are not sure if you take an MAOI, ask your healthcare provider or pharmacist.
Before starting and while taking SAVELLA, tell your healthcare provider:
- About all your prescriptions and over-the-counter medicines and supplements you take or plan to take, including:
- Medicines for migraines, including triptans
- Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or MAOIs
- Tramadol, fentanyl, meperidine, methadone, or other opioids
- The blood thinner warfarin (Coumadin, Jantoven)
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen, naproxen, or aspirin)
- Over-the-counter supplements such as tryptophan or St. John's Wort
Your healthcare provider or pharmacist can tell you if it is safe to take SAVELLA with your other medications. Do not start or stop any medicine while taking SAVELLA without talking to your healthcare provider first.
- About all your health problems, especially the following: heart, liver, kidney, or bleeding problems; high blood pressure; seizures or convulsions; bipolar disorder or mania; low sodium levels in your blood.
- About how often you drink alcohol and how much you drink.
- If you are pregnant or plan to become pregnant during therapy. It is not known if SAVELLA will harm your unborn baby.
- The use of SNRIs late in pregnancy may be associated with an increased risk of postpartum bleeding and may cause complications for your baby. Talk to your healthcare provider about the risks to you and your baby if you take SAVELLA during pregnancy.
- There is a pregnancy registry for females who are exposed to SAVELLA during pregnancy. The purpose of the registry is to collect information about the health of pregnant females exposed to SAVELLA and their babies. If you become pregnant during treatment with SAVELLA, talk to your healthcare provider about how you can take part in this registry, or you may call the registry directly at 1-877-643-3010 or go to www.savellapregnancyregistry.com.
- If you are breastfeeding or plan to breastfeed.
- SAVELLA can pass into your breast milk and may harm your baby. Your healthcare provider can advise on the best way to feed your baby and what to watch for while taking SAVELLA.
Other Safety Information related to SAVELLA:
- SAVELLA may cause sleepiness and dizziness. Until you know how SAVELLA affects you, you shouldn't drive a car or operate hazardous machinery.
Most common side effects of SAVELLA:
- Nausea, headache, constipation, dizziness, insomnia, hot flush, excessive sweating, vomiting, palpitations, increased heart rate, dry mouth, and increased blood pressure. This is not a complete list.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please see full Prescribing Information, including Boxed Warning