SAVELLA is not used to treat depression, but it acts like medicines that are used to treat
depression (antidepressants) and other psychiatric disorders. Antidepressants may increase
suicidal thoughts or actions in some children, teenagers, and young adults. Call your doctor
right away or seek emergency help if you have new or worsening additional symptoms, unusual
changes in behavior, mood, thoughts or feelings, thoughts of suicide, anxiety, agitation,
panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity,
restlessness, or extreme hyperactivity. Call your healthcare 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 after a change in the dose. SAVELLA is
approved only for adults aged 18 and older. For more information about this risk, please read
the SAVELLA Patient Medication Guide in the Full Prescribing Information.
See additional Important Risk Information below
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:
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Suicidal thoughts or actions:
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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.
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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.
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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:
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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:
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About all your prescriptions and over-the-counter medicines and supplements you take or plan
to take including:
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Medicines for migraines, mood, or psychotic disorders to avoid a potentially
life-threatening condition
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Aspirin, NSAID pain relievers, or blood thinners, because they may increase the risk
for bleeding
- About all your health problems.
- About how often you drink alcohol and how much you drink.
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If you are pregnant or plan to become pregnant during therapy. It is not known if SAVELLA
will harm your unborn baby.
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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.
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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.
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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:
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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:
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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.
Use
SAVELLA®
(milnacipran HCl) is a prescription medication used to manage fibromyalgia. It is not known if
SAVELLA is safe and effective in children.
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.
