exubera- insulin human exubera- insulin human aerosol, powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

insulin human (UNII: 1Y17CTI5SR) (insulin human - UNII:1Y17CTI5SR)

Available from:

Pfizer Inc.

INN (International Name):

insulin human

Pharmaceutical form:

KIT

Composition:

1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins. EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of its excipients. EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see CLINICAL PHARMACOLOGY, Special Populations, Smoking). The safety and efficacy of EXUBE

Product summary:

EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars. Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant. EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA® Inhaler, and replacement EXUBERA® Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA® Inhaler consists of the inhaler base, a chamber, and an EXUBERA® Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component. EXUBERA® Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA® Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations. Blister Storage Not in-use (Unopened): Store at controlled room temperature, 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate. In-use: Once the foil overwrap is opened, unit dose blisters should be protected from moisture, stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate. Unit dose blisters should be used within 3 months after opening the foil overwrap. Return the blisters to the overwrap to protect from moisture. Additional care should be taken to avoid humid environments, e.g. steamy bathroom following a shower. Discard blister if frozen. Inhaler Storage Store at controlled room temperature, 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate. The EXUBERA® Inhaler can be used for up to 1 year from the date of first use. Replacing The EXUBERA® Release Unit The EXUBERA® Release Unit in the EXUBERA® Inhaler should be changed every 2 weeks. Keep out of reach of children

Patient Information leaflet

EXUBERA- INSULIN HUMAN
EXUBERA- INSULIN HUMAN AEROSOL, POWDER
Pfizer Inc.
----------
MEDICATION GUIDE
EXUBERA® (EG-ZU-BER-UH)
(INSULIN HUMAN [RDNA ORIGIN]) INHALATION POWDER
Carefully read the Instructions for Use at the end of this Medication
Guide, so you will be sure to get the
right amount of your insulin.
Read this Medication Guide that comes with EXUBERA before you start
using it, and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking with your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about EXUBERA?
•
EXUBERA is a prescription medicine that contains an insulin powder
that you breathe in (inhale)
through your mouth using the EXUBERA® Inhaler. It is used to treat
adults with diabetes. It helps
to control high blood sugar.
•
Do not use EXUBERA if you smoke, start smoking, or if you quit smoking
less than 6 months
ago. Smoking can increase the amount of EXUBERA you get and may cause
your blood sugar to
get dangerously low. If you smoke, or you quit smoking less than 6
months ago, you will need a
different treatment for your diabetes.
•
EXUBERA may lower your lung function, so:
•
You need to have lung tests before you start EXUBERA, and after you
start EXUBERA,
you may need to have lung tests again later as directed by your
healthcare provider.
•
EXUBERA is not recommended for people that have chronic lung disease
(such as asthma
or chronic obstructive pulmonary disease or emphysema).
•
Also, EXUBERA should not be used at all by people with unstable or
poorly controlled lung
disease.
•
The dose of EXUBERA is different from other insulin. Make sure you
take the exact dose of
EXUBERA that your healthcare provider prescribes.
•
EXUBERA comes in 1 mg dose or in 3 mg dose "blisters", which are small
foil dose packets.
"Blister" is a standard term for the shape and type of foil dose
packet that holds the insulin
powder. Each individual dose of EXUBERA is enclosed

Summary of Product characteristics

EXUBERA- INSULIN HUMAN
EXUBERA- INSULIN HUMAN AEROSOL, POWDER
PFIZER INC.
----------
EXUBERA
(INSULIN HUMAN [RDNA ORIGIN]) INHALATION POWDER
EXUBERA INHALER
RX ONLY
DESCRIPTION
EXUBERA consists of blisters containing human insulin inhalation
powder, which are administered
using the EXUBERA Inhaler. EXUBERA blisters contain human insulin
produced by recombinant
DNA technology utilizing a non-pathogenic laboratory strain of
_Escherichia coli_ (K12). Chemically,
human insulin has the empirical formula C
H
N O S and a molecular weight of 5808. Human
insulin has the following primary amino acid sequence:
EXUBERA (insulin human [rDNA origin]) Inhalation Powder is a white to
off-white powder in a unit
dose blister (fill mass, see Table 1). Each unit dose blister of
EXUBERA contains a 1 mg or 3 mg dose
of insulin (see Table 1) in a homogeneous powder formulation
containing sodium citrate (dihydrate),
mannitol, glycine, and sodium hydroxide. After an EXUBERA blister is
inserted into the inhaler, the
patient pumps the handle of the inhaler and then presses a button,
causing the blister to be pierced. The
insulin inhalation powder is then dispersed into the chamber, allowing
the patient to inhale the
aerosolized powder.
Under standardized _in vitro_ test conditions, EXUBERA delivers a
specific emitted dose of insulin from
the mouthpiece of the inhaler (see Table 1). A fraction of the total
particle mass is emitted as fine
particles capable of reaching the deep lung. Up to 45% of the 1 mg
blister contents, and up to 25% of
the 3 mg blister contents, may be retained in the blister.
TABLE 1: DOSE NOMENCLATURE AND INFORMATION
FILL MASS
(MG POWDER)
NOMINAL DOSE
(MG INSULIN)
EMITTED DOSE
(MG INSULIN)
FINE PARTICLE DOSE
(MG INSULIN)
®
®
®
®
257
383
65
77
6
*,†
‡ ,†
*
†
‡
1.7
1.0
0.53
0.4
5.1
3.0
2.03
1.0
The actual amount of insulin delivered to the lung will depend on
individual patient factors, such as
inspiratory flow profile. _In vitro_, emitted aerosol metrics are
unaffected at flow rates above 10 L/min.
CLINICA