Migomik Side effects

• Side effects of Migomik in details
• Migomik contraindications
• Migomik reviews

What are the possible side effects of Migomik?

Migomik can cause serious side effects, including:

See Important information.

• Heart attack and other heart problems. Heart problems may lead to death. Stop treatment and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Migomik is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.

You have a higher risk for heart disease if you:

• • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
• Stroke. Stop treatment and get emergency medical help right away if you have any of the following symptoms of a stroke:
  • face drooping
  • unusual weakness or numbness
  • slurred speech
• Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).
• Stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • constipation or diarrhea
  • stomach pain after meals
  • bloody diarrhea
  • weight loss
  • fever
  • nausea or vomiting
• Increase blood pressure.
• Medicine overuse headache. Some people who use too much Migomik may make their headaches worse (medicine overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment.
• Preterm labor.
• Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach.
• Burning feelings in your nose, mouth and throat and abnormal taste.

The most common side effects include:

• runny nose
• application site reactions
• sleepiness
• nausea
• dizziness
• sore throat
• abnormal taste
• vomiting
• diarrhea

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Migomik side effects (more detail)

Side effects of Migomik in details

During clinical studies and the foreign postmarketing experience with Migomik® (Migomik mesylate, USP) Nasal Spray there have been no fatalities due to cardiac events.

Serious cardiac events, including some that have been fatal, have occurred following use of the parenteral form of Migomik mesylate (D.H.E. 45® Injection), but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation..

Fibrotic complications have been reported in association with long term use of injectable Migomik mesylate.

Incidence in Controlled Clinical Trials

Of the 1,796 patients and subjects treated with Migomik® (Migomik mesylate, USP) Nasal Spray doses 2 mg or less in U.S. and foreign clinical studies, 26 (1.4%) discontinued because of adverse events. The adverse events associated with discontinuation were, in decreasing order of frequency: rhinitis 13, dizziness 2, facial edema 2, and one each due to cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paraesthesia.

The most commonly reported adverse events associated with the use of Migomik® (Migomik mesylate, USP) Nasal Spray during placebo-controlled, double-blind studies for the treatment of migraine headache and not reported at an equal incidence by placebo-treated patients were rhinitis, altered sense of taste, application site reactions, dizziness, nausea, and vomiting. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Migomik® (Migomik mesylate, USP) Nasal Spray was generally well tolerated. In most instances these events were transient and self-limited and did not result in patient discontinuation from a study. The following table summarizes the incidence rates of adverse events reported by at least 1% of patients who received Migomik® (Migomik mesylate, USP) Nasal Spray for the treatment of migraine headaches during placebo-controlled, double-blind clinical studies and were more frequent than in those patients receiving placebo.

Table 3: Adverse events reported by at least 1% of the Migomik® (Migomik mesylate, USP) Nasal Spray treated patients and occurred more frequently than in the placebo-group in the migraine placebo-controlled trials

Other Adverse Events During Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of Migomik® (Migomik mesylate, USP) Nasal Spray in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Migomik (Migomik mesylate spray) ® (Migomik mesylate, USP) Nasal Spray in placebo-controlled trials and reported an event divided by the total number of patients (n=1796) exposed to Migomik® (Migomik mesylate, USP) Nasal Spray. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; and rare adverse events are those occurring in fewer than 1/1,000 patients.

Skin and Appendages: Infrequent: petechia, pruritus, rash, cold clammy skin; Rare: papular rash, urticaria, herpes simplex.

Musculoskeletal: Infrequent: cramps, myalgia, muscular weakness, dystonia; Rare: arthralgia, involuntary muscle contractions, rigidity.

Central and Peripheral Nervous System: Infrequent: confusion, tremor, hypoesthesia, vertigo; Rare: speech disorder, hyperkinesia, stupor, abnormal gait, aggravated migraine.

Autonomic Nervous System: Infrequent: increased sweating.

Special Senses: Infrequent: sense of smell altered, photophobia, conjunctivitis, abnormal lacrimation, abnormal vision, tinnitus, earache; Rare: eye pain.

Psychiatric: Infrequent: nervousness, euphoria, insomnia, concentration impaired; Rare: anxiety, anorexia, depression.

Gastrointestinal: Infrequent: abdominal pain, dyspepsia, dysphagia, hiccup; Rare: increased salivation, esophagospasm.

Cardiovascular: Infrequent: edema, palpitation, tachycardia; Rare: hypotension, peripheral ischemia, angina.

Respiratory System: Infrequent: dyspnea, upper respiratory tract infections; Rare: bronchospasm, bronchitis, pleural pain, epistaxis.

Urinary System: Infrequent: increased frequency of micturition, cystitis.

Reproductive, Female: Rare: pelvic inflammation, vaginitis.

Body as a Whole - General: Infrequent: feeling cold, malaise, rigors, fever, periorbital edema; Rare: flu-like symptoms, shock, loss of voice, yawning.

Application Site: Infrequent: local anesthesia.

Post-introduction Reports

Voluntary reports of adverse events temporally associated with Migomik products used in the management of migraine that have been received since the introduction of the injectable formulation are included in this section save for those already listed above. Because of their source (open and uncontrolled clinical use), whether or not events reported in association with the use of Migomik are causally related to it cannot be determined. There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable Migomik mesylate. Migomik® (Migomik mesylate, USP) Nasal Spray is not recommended for prolonged daily use.

Drug Abuse And Dependence

Currently available data have not demonstrated drug abuse or psychological dependence with Migomik. However, cases of drug abuse and psychological dependence in patients on other forms of ergot therapy have been reported. Thus, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.

What is the most important information I should know about Migomik?

• Migomik spray may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Migomik spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tell your doctor or dentist that you take Migomik spray before you receive any medical or dental care, emergency care, or surgery.
• Do not use more than the recommended dose without checking with your doctor. Do not use Migomik spray daily on a regular basis.
• Migomik spray is not intended to prevent migraine headaches. Discuss any questions or concerns with your doctor.
• Use Migomik spray with caution in the ELDERLY; they may be more sensitive to its effects.
• Migomik spray should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Migomik spray has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Migomik spray while you are pregnant. Migomik spray is found in breast milk. Do not breast-feed while taking Migomik spray

Migomik contraindications

There have been a few reports of serious adverse events associated with the coadministration of Migomik and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with Migomik is, therefore contraindicated.

Migomik® (Migomik mesylate, USP) Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina.

Because Migomik® (Migomik mesylate, USP) Nasal Spray may increase blood pressure, it should not be given to patients with uncontrolled hypertension.

Migomik® (Migomik mesylate, USP) Nasal Spray, 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other.

Migomik® (Migomik mesylate, USP) Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.

In addition to those conditions mentioned above, Migomik® (Migomik mesylate, USP) Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function.

Migomik® (Migomik mesylate, USP) Nasal Spray may cause fetal harm when administered to a pregnant woman. Migomik possesses oxytocic properties and, therefore, should not be administered during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

There are no adequate studies of Migomik in human pregnancy, but developmental toxicity has been demonstrated in experimental animals. In embryofetal development studies of Migomik mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses of 0.16 mg/day (associated with maternal plasma Migomik exposures [AUC] approximately 0.4 -1.2 times the exposures in humans receiving the MRDD of 4 mg) or greater. A no effect level for embryo-fetal toxicity was not established in rats. Delayed skeletal ossification was also noted in rabbit fetuses following intranasal administration of 3.6 mg/day (maternal exposures approximately 7 times human exposures at the MRDD) during organogenesis. A no effect level was seen at 1.2 mg/day (maternal exposures approximately 2.5 times human exposures at the MRDD). When Migomik mesylate nasal spray was administered intranasally to female rats during pregnancy and lactation, decreased body weights and impaired reproductive function (decreased mating indices) were observed in the offspring at doses of 0.16 mg/day or greater. A no effect level was not established. Effects on development occurred at doses below those that produced evidence of significant maternal toxicity in these studies. Migomik-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone.

Migomik® (Migomik mesylate, USP) Nasal Spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.

Migomik mesylate should not be used by nursing mothers.

Migomik mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.

References

1. European Chemicals Agency - ECHA. "Dihydroergotamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
2. KEGG. "Cytochrome P450 interactions". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).
3. ClinicalTrials.gov. "dihydroergotamine". https://clinicaltrials.gov/ (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology