baqsimi
Pharmaranks rates Baqsimi 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Baqsimi (Glucagon) is an antihypoglycemic agent used to treat Anaphylaxis, Bradycardia, Hypoglycemia, Hypotension.
Glucagon · by Amphastar Pharms Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Glucagon
- Drug class
- Antihypoglycemic Agent
- Form
- Powder
- Strength
- Glucagon 3MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- anaphylaxis, bradycardia, hypoglycemia
- Manufacturer
- Amphastar Pharms Inc
- What the pharmacy pays
- ~$5930.62 for 30 — not your price
- FDA application
- NDA210134
What is Baqsimi?
From the FDA label:BAQSIMI contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single-chain polypeptide containing 29 amino acid residues and has a molecular weight of 3483, and is identical to human glucagon. Its molecular formula is C 153 H 225 N 43 O 49 S, with the following molecular structure: BAQSIMI is a preservative-free, white powder for intranasal administration in an intranasal device containing one dose of 3 mg glucagon. BAQSIMI contains glucagon as the active ingredient and betadex, and dodecylphosphocholine as the excipients. structure
How to use
BAQSIMI is for intranasal use only. ( 2.1 ) The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril. ( 2.2 ) Administer BAQSIMI according to the printed instructions on the shrink-wrapped tube label and the Instructions for Use. ( 2.1 ) Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line is no longer showing. The dose does not need to be inhaled. ( 2.1 ) Call for emergency assistance immediately after administering the dose. ( 2.1 ) When the patient responds to treatment, give oral carbohydrates. ( 2.1 ) Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot be reused. Discard any unused portion. ( 2.1 ) If there has been no response after 15 minutes, an additional 3 mg dose may be administered while waiting for emergency assistance. ( 2.2 ) 2.1 Important Administration Instructions BAQSIMI is for intranasal use only. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires help of others to recover, instruct the patient to inform those around them about BAQSIMI and its Instructions for Use. Administer BAQSIMI as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the…
Side effects
The following clinically significant adverse reactions are described elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . Lack of Efficacy in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] . Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, itchy nose, throat and eyes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflect the rates observed in practice. Adverse Reactions in Adult Patients Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single intranasal dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon…
Warnings
Important safety information
Substantial Increase in Blood Pressure in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because BAQSIMI may stimulate the release of catecholamines from the tumor. ( 5.1 ) Hypoglycemia in Patients with Insulinoma : In patients with insulinoma, administration may produce an initial increase in blood glucose; however, BAQSIMI may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously. ( 5.2 ) Serious Hypersensitivity Reactions : Serious hypersensitivity reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. ( 5.3 ) Lack of Efficacy in Patients with Decreased Hepatic Glycogen : BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose. ( 5.4 ) 5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor [see Contraindications ( 4 )]. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure. 5.2 Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma [see Contraindications ( 4 )]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously. 5.3 Serious Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications ( 4 )]. 5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia [see Clinical Pharmacology ( 12.2 )]. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.
Who should not take Baqsimi
BAQSIMI is contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions ( 5.1 )] Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Known hypersensitivity to glucagon or to any of the excipients ( 4 )
Overdose — what happens if you take too much
If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium levels may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. In the event of an overdose of BAQSIMI, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendation.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin : In patients taking indomethacin BAQSIMI may lose its ability to raise glucose or may produce hypoglycemia. ( 7.2 ) Warfarin : BAQSIMI may increase the anticoagulant effect of warfarin. ( 7.3 ) 7.1 Beta-blockers Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. 7.2 Indomethacin In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. 7.3 Warfarin BAQSIMI may increase the anticoagulant effect of warfarin.
Drug class
- Antihypoglycemic Agent
- Gastrointestinal Motility Inhibitor
May treat (source: NIH RxClass)
See how Baqsimi ranks — best-rated antihypoglycemic agent for:
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Baqsimi treat?
- Baqsimi (Glucagon) may be used to treat anaphylaxis, bradycardia, hypoglycemia, hypotension, cardiogenic shock, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Baqsimi rated?
- pharmaranks gives Baqsimi a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Baqsimi cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5930.62 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Baqsimi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Baqsimi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Baqsimi?
- Baqsimi is marketed by Amphastar Pharms Inc. You can see Amphastar Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Baqsimi a brand-name or generic drug?
- Baqsimi is a brand-name product with the active ingredient Glucagon.
- Is Baqsimi available over the counter?
- No. Baqsimi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Baqsimi come in?
- Baqsimi is currently marketed as powder, per the FDA's National Drug Code Directory.
- What class of drug is Baqsimi?
- Baqsimi is classified as antihypoglycemic agent, gastrointestinal motility inhibitor, per the FDA's Established Pharmacologic Class.
- Is Baqsimi FDA-registered?
- Baqsimi is on record with the U.S. FDA under application number NDA210134. You can verify this on its official FDA label.
- Has Baqsimi been recalled by the FDA?
- Baqsimi has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Baqsimi safe?
- There's no single safe-or-not verdict. pharmaranks gives Baqsimi a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Baqsimi?
- Baqsimi's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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baqsimi
70/100