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INSULIN HUMAN
At a glance
| Generic name | INSULIN HUMAN |
|---|---|
| Drug class | Insulin [EPC] |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
Boxed warnings
- WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4 )]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE See full prescribing information for complete boxed warning. Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). ( 5.1 ) AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. ( 4 ) Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients. ( 2.5 ), ( 5.1 )
Common side effects
- Weight gain
- Peripheral Edema
- Lipodystrophy
- Localized Cutaneous Amyloidosis
- Injection Site Reactions
- Allergic Reactions
- Anaphylaxis
- Generalized skin reactions
- Rash
- Angioedema
- Bronchospasm
- Hypotension
Key clinical trials
- Text Message for Adolescents With Poorly Controlled Type 1 Diabetes (NA)
- Epigenetic Regulation of Human Adipose Tissue Distribution (NA)
- Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance (PHASE4)
- Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity (PHASE2)
- Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD
- Assessments of Adipogenesis, Lipid Turnover and Cellular Composition in Adipose Tissue in Response to Endurance Exercise (NA)
- Critical Food Ingredients on Immunocompetence to Prevent the Risk and Development of Obesity/Metabolic Syndrome (NA)
- Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |