Mitigo (injection)

Mitigo is an opioid medicine that treats severe chronic pain in adults and children when other treatments are not suitable.

Mitigo may also be used for other reasons not mentioned in this medication guide.

Never share opioid medicine with anyone else, especially someone who has a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot access it. Selling or giving away Mitigo is against the law.

Fatal side effects may happen if you drink alcohol or use other drugs that cause drowsiness or slow breathing while taking this medicine.

Using opioid medicine during pregnancy may lead to life-threatening withdrawal symptoms in the newborn.

You should not use Mitigo if you are allergic to it, or if you have:

• severe asthma or breathing problems;
• used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine; or
• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have or have ever had:

• breathing problems, sleep apnea (breathing that stops during sleep);
• a head injury, brain tumor, or seizures;
• a drug or alcohol addiction, or mental illness;
• urination problems;
• problems with your bile duct, pancreas, or adrenal gland; or
• kidney or liver disease.

If you use Mitigo during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor before using an opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Mitigo may affect fertility in men or women when used for a long time. Ask your doctor about your individual risk.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, which can lead to death. A person caring for you should give naloxone and/or seek emergency medical help if you have slow breathing with long pauses, blue lips, or if you are difficult to wake up.

Mitigo may cause serious side effects. Call your doctor right away if you experience:

• slow heart rate, sighing, shallow breathing, or breathing that stops;
• extreme drowsiness, feeling faint;
• flushing (sudden warmth, redness, or tingling);
• a seizure;
• severe pain caused by opioids;
• low levels of sex hormones (androgens);
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, increased tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are weak or have wasting syndrome or chronic breathing disorders.

Common side effects of Mitigo may include:

• breathing problems;
• drowsiness, dizziness;
• constipation, nausea, vomiting;
• sweating; or
• numbness, tingling, or cold feeling in your hands and feet.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Mitigo in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Mitigo.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

A healthcare provider will give you this injection.

You may have withdrawal symptoms if you stop using Mitigo suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep the auto-injector in its original container until you are ready to use it.

Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.

Call your doctor for instructions if you miss an appointment for your Mitigo (injection).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Mitigo will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Many other medications can be harmful when taken with opioid medicine. Inform your doctor if you are also using:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicines;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• sleep medicine, muscle relaxers, or other medications that cause drowsiness; or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many medications may interact with Mitigo, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are included here.