Afrezza

What Is Afrezza?

Afrezza (insulin human) Inhalation Powder is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

What Are Side Effects of Afrezza?

Common side effects of Afrezza include:

• low blood sugar (hypoglycemia),
• cough,
• sore throat,
• headache,
• diarrhea,
• fatigue,
• nausea,
• bronchitis,
• urinary tract infection, and
• weight gain.

Dosage for Afrezza

Afrezza Inhalation Powder is available as 4 unit and 8 unit single use cartridges to be administered via oral inhalation using a single inhalation per cartridge.

What Drugs, Substances, or Supplements Interact with Afrezza?

Afrezza may interact with antidiabetic drugs, ACE inhibitors, angiotensin II receptor blockers, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics, antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic agents, thyroid hormones, alcohol, beta-blockers, clonidine, lithium salts, pentamidine, clonidine, guanethidine, and reserpine. Tell your doctor all medications and supplements you use.

Afrezza During Pregnancy and Breastfeeding

During pregnancy, Afrezza should be used only if prescribed. This drug may pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Afrezza (insulin human) Inhalation Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Afrezza Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an insulin injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• bronchospasm (wheezing, chest tightness, trouble breathing);
• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;
• cough; or
• sore throat.

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 Afrezza (Insulin Human Inhalation Powder)

 

Afrezza Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

• Acute bronchospasm in patients with chronic lung disease [see WARNING AND PRECAUTIONS]
• Hypoglycemia [see WARNING AND PRECAUTIONS]
• Decline in pulmonary function [see WARNING AND PRECAUTIONS]
• Lung cancer [see WARNING AND PRECAUTIONS]
• Diabetic ketoacidosis [see WARNING AND PRECAUTIONS]
• Hypersensitivity reactions [see WARNING 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure of 3017 patients to AFREZZA and include 1026 patients with type 1 diabetes and 1991 patients with type 2 diabetes. The mean exposure duration was 8.17 months for the overall population and 8.16 months and 8.18 months for type 1 and 2 diabetes patients, respectively. In the overall population, 1874 were exposed to AFREZZA for 6 months and 724 for greater than one year. 620 and 1254 patients with type 1 and type 2 diabetes, respectively, were exposed to AFREZZA for up to 6 months. 238 and 486 patients with type 1 and type 2 diabetes, respectively, were exposed to AFREZZA for greater than one year (median exposure = 1.8 years). AFREZZA was studied in placebo and active-controlled trials (n = 3 and n = 10, respectively).

The mean age of the population was 50.2 years and 20 patients were older than 75 years of age. 50.8% of the population were men; 82.6% were White, 1.8% were Asian, and 4.9% were Black or African American. 9.7% were Hispanic. At baseline, the type 1 diabetes population had diabetes for an average of 16.6 years and had a mean HbA1c of 8.3%, and the type 2 diabetes population had diabetes for an average of 10.7 years and had a mean HbA1c of 8.8%. At baseline, 33.4% of the population reported peripheral neuropathy, 32.0% reported retinopathy and 19.6% had a history of cardiovascular disease.

Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of AFREZZA in the pool of controlled trials in type 2 diabetes patients. These adverse reactions were not present at baseline, occurred more commonly on AFREZZA than on placebo and/or comparator and occurred in at least 2% of patients treated with AFREZZA.

Table 1: Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with AFREZZA

	Placebo* (n = 290)	AFREZZA (n = 1991)	Non-placebo comparators (n=1363)
Cough	19.7%	25.6%	5.4%
Throat pain or irritation	3.8%	4.4%	0.9%
Headache	2.8%	3.1%	1.8%
Diarrhea	1.4%	2.7%	2.2%
Productive cough	1.0%	2.2%	0.9%
Fatigue	0.7%	2.0%	0.6%
Nausea	0.3%	2.0%	1.0%
*Carrier particle without insulin was used as placebo [see DESCRIPTION].

Table 2 shows common adverse reactions, excluding hypoglycemia, associated with the use of AFREZZA in the pool of active-controlled trials in type 1 diabetes patients. These adverse reactions were not present at baseline, occurred more commonly on AFREZZA than on comparator, and occurred in at least 2% of patients treated with AFREZZA.

Table 2: Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with AFREZZA

	Subcutaneous Insulin (n = 835)	AFREZZA (n=1026)
Cough	4.9%	29.4%
Throat pain or irritation	1.9%	5.5%
Headache	2.8%	4.7%
Pulmonary function test decreased	1.0%	2.8%
Bronchitis	2.0%	2.5%
Urinary tract infection	1.9%	2.3%

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including AFREZZA [see WARNING AND PRECAUTIONS]. The incidence of severe and non-severe hypoglycemia of AFREZZA versus placebo in patients with type 2 diabetes is shown in Table 3. A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia. Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia.

Table 3: Incidence of Severe and Non-Severe Hypoglycemia in a Placebo-Controlled Study of Patients with Type 2 Diabetes

	Placebo (N=176)	AFREZZA (N=177)
Severe Hypoglycemia	1.7%	5.1%
Non-Severe Hypoglycemia	30%	67%

Cough

Approximately 27% of patients treated with AFREZZA reported cough, compared to approximately 5.2% of patients treated with comparator. In clinical trials, cough was the most common reason for discontinuation of AFREZZA therapy (2.8% of AFREZZA-treated patients).

Pulmonary Function Decline

In clinical trials lasting up to 2 years, excluding patients with chronic lung disease, patients treated with AFREZZA had a 40 mL (95% CI: -80, -1) greater decline from baseline in forced expiratory volume in one second (FEV₁) compared to patients treated with comparator anti-diabetes treatments. The decline occurred during the first 3 months of therapy and persisted over 2 years (Figure 2). A decline in FEV₁ of ≥ 15% occurred in 6% of AFREZZA-treated subjects compared to 3% of comparator-treated subjects.

Figure 2: Mean (+/-SE) Change in FEV₁ (Liters) from Baseline for Type 1 and Type 2 Diabetes Patients

Weight Gain

Weight gain may occur with some insulin therapies, including AFREZZA. Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria. In a clinical trial of patients with type 2 diabetes [see Clinical Studies], there was a mean 0.49 kg weight gain among AFREZZA-treated patients compared with a mean 1.13 kg weight loss among placebo-treated patients.

Antibody Production

Increases in anti-insulin antibody concentrations have been observed in patients treated with AFREZZA. Increases in anti-insulin antibodies are observed more frequently with AFREZZA than with subcutaneously injected mealtime insulins. Presence of antibody did not correlate with reduced efficacy, as measured by HbA1c and fasting plasma glucose, or specific adverse reactions.

Read the entire FDA prescribing information for Afrezza (Insulin Human Inhalation Powder)