Alsuma
- Generic Name: sumatriptan injection
- Brand Name: Alsuma
Alsuma (Sumatriptan Injection) side effects drug center
Alsuma Side Effects Center
Alsuma (sumatriptan) Auto-Injector is a triptan used to treat migraine headaches and cluster headaches. Alsuma will only treat a headache that has already begun. Alsuma will not prevent headaches or reduce the number of attacks. Alsuma should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Common side effects of Alsuma include:
- flushing (warmth, redness, or tingling under your skin)
- sensations of tingling/numbness/prickling/heat, weakness, drowsiness, dizziness, spinning sensation, mild headache (not a migraine)
- pressure or heavy feeling in any part of your body
- discomfort in your nose or throat
- muscle pain
- neck pain or stiffness, or
- injection site reactions (pain, redness, swelling, bleeding, or bruising)
The maximum single recommended adult dose of Alsuma is 6 mg injected subcutaneously. Alsuma may interact with antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Alsuma should be used only if prescribed. This drug passes into breast milk and may have undesirable effects on a nursing infant. Avoid breastfeeding for at least 12 hours after using Alsuma. Consult your doctor before breastfeeding.
Our Alsuma (sumatriptan) Auto-Injector Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Alsuma Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor at once if you have:
- sudden and severe stomach pain and bloody diarrhea;
- severe chest pain, shortness of breath, irregular heartbeats;
- a seizure (convulsions);
- blood circulation problems in your legs or feet--cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common side effects may include:
- numbness, tingling, warmth, redness, or burning sensation;
- pressure or heavy feeling in any part of your body;
- dizziness, drowsiness, feeling weak or tired;
- neck pain or stiffness; or
- pain or redness where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Alsuma (Sumatriptan Injection)
Alsuma Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Migraine Headache
Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [Studies 2 and 3, see Clinical Studies] following either a single 6-mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1: Adverse Reactions Reported by at Least 2% of
Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled
Migraine Clinical Trials (Studies 2 and 3)a
| Adverse Reaction | Percent of Subjects Reporting | |
| Sumatriptan 6 mg Subcutaneous (n = 547) |
Placebo (n = 370) |
|
| Atypical sensations | 42 | 9 |
| Tingling | 14 | 3 |
| Warm/hot sensation | 11 | 4 |
| Burning sensation | 7 | < 1 |
| Feeling of heaviness | 7 | 1 |
| Pressure sensation | 7 | 2 |
| Feeling of tightness | 5 | < 1 |
| Numbness | 5 | 2 |
| Feeling strange | 2 | < 1 |
| Tight feeling in head | 2 | < 1 |
| Cardiovascular | ||
| Flushing | 7 | 2 |
| Chest Discomfort | 5 | 1 |
| Tightness in chest | 3 | < 1 |
| Pressure in chest | 2 | < 1 |
| Ear, nose and throat | ||
| Throat discomfort | 3 | < 1 |
| Discomfort: nasal cavity/sinuses | 2 | < 1 |
| Injection site reactionb | 59 | 24 |
| Miscellaneous Jaw discomfort | 2 | 0 |
| Musculoskeletal | ||
| Weakness | 5 | < 1 |
| Neck pain/stiffness | 5 | < 1 |
| Myalgia | 2 | < 1 |
| Neurological | ||
| Dizziness/vertigo | 12 | 4 |
| Drowsiness/sedation | 3 | 2 |
| Headache | 2 | < 1 |
| Skin | ||
| Sweating | 2 | 1 |
| a The sum of the percentages cited is greater
than 100% because subjects may have experienced more than 1 type of adverse
reaction. Only reactions that occurred at a frequency of 2% or more in groups
treated with sumatriptan injection and occurred at a frequency greater than the
placebo groups are included. b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding. |
||
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Cluster Headache
In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache [Studies 4 and 5, see Clinical Studies], no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects with migraine.
Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).
Adverse Reactions Observed In Association With The Administration of ALSUMA
The safety of ALSUMA was evaluated in an open-label clinical trial evaluating the usability of ALSUMA during a migraine attack. Adverse reactions that occurred at a frequency of 5% or higher were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).
Read the entire FDA prescribing information for Alsuma (Sumatriptan Injection)
© Alsuma Patient Information is supplied by Cerner Multum, Inc. and Alsuma Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.