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Please carefully review the following safety information related to the use of this medication. It is important to understand the potential risks and precautions. Consult your healthcare provider if you have any questions or concerns.

• Serotonin Syndrome Risk: This medication may increase the risk of serotonin syndrome, a rare but potentially life-threatening condition resulting from elevated serotonin levels in the body. The risk is heightened when Akynzeo (netupitant / palonosetron) is used in conjunction with other medications that also increase serotonin levels.

  • Precaution: Inform your healthcare provider about all medications you are currently taking before starting Akynzeo. Do not begin any new medications without consulting your provider or pharmacist.
  • Symptoms: Be alert for signs such as mental changes (e.g., restlessness, hallucinations, delirium, or coma), rapid heart rate, fluctuations in blood pressure, dizziness, sweating, flushing, sensation of heat, tremors, muscle stiffness, involuntary muscle movements, twitching, spasms, loss of coordination, or seizures.
  • Emergency Action: If you or someone else experiences these symptoms, seek immediate medical assistance by calling 911.

• Interaction Risks: The chance of developing serotonin syndrome increases when taken with drugs that also enhance serotonin levels, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), or triptans.

Please ensure to discuss all potential interactions with your healthcare provider to ensure safe and effective use of the medication.

When taking this medication, some people may experience common side effects such as headache, which occurs in about 9% of users, as well as weakness, fatigue, indigestion, constipation, and skin redness. These effects are generally mild but consult your healthcare provider if they persist or worsen.

In rare instances, the medication may lead to serotonin syndrome, a serious condition. Symptoms to watch for include changes in mental status such as agitation, hallucinations, or confusion, as well as fast heart rate, blood pressure changes, dizziness, and muscle stiffness or twitching. If these occur, immediate medical attention is necessary.

Additionally, serious allergic reactions are possible but uncommon. Be vigilant for signs like hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Should any of these symptoms develop, seek urgent medical care without delay.

These lists do not cover all possible side effects. For any other unusual symptoms or if you have concerns, please contact your healthcare provider for further advice.

This medication can impact how other drugs are cleared from your body, potentially altering their effectiveness. Examples of drugs that may be affected include elacestrant, Flibanserin, and lomitapide. Additionally, other substances can influence how this medication is processed in your body, which may affect its performance. Examples of such substances are rifamycins like Rifampin and herbal supplements like St. John's wort.

Moreover, there is an increased risk of serotonin syndrome or toxicity if you are taking other medications that elevate serotonin levels. This includes recreational drugs like MDMA or "ecstasy," herbal supplements like St. John's wort, and certain antidepressants, such as SSRIs (e.g., Fluoxetine, paroxetine) and SNRIs (e.g., Duloxetine, Venlafaxine). The risk of serotonin syndrome or toxicity is heightened when these drugs are introduced or their dosages are increased.