Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler® Family of Inhalers to Support Asthma Management
06 Juni 2023 - 2:00PM
Business Wire
Via the PhilRx Patient Access Platform,
patients can now access Teva Pharmaceuticals’ Digihaler® family of
inhalers
Phil Inc., a patient access platform company that revolutionizes
life science product commercialization, today announced an
agreement with Teva Pharmaceuticals that will make Digihaler®
products available for prescription using the PhilRx Patient Access
Platform. Teva’s Digihaler system is the first and only smart
inhaler system that can provide objective inhaler data to help
patients and their doctors have informed treatment discussion in
support of asthma management.
The goal of Phil and Teva Pharmaceuticals’ partnership is to
help enable patients to receive and refill their Digihaler
medication quickly, easily and affordably. Using the PhilRx Patient
Access Platform, patients can fill their prescription, review
prescription records and obtain assistance navigating insurance
benefits.
The PhilRx Patient Access Platform provides end-to-end
visibility into the entire prescription life cycle, starting when
the physician writes the prescription. Physicians can select the
PhilRx Patient Access Platform directly from an electronic medical
record (EMR) to submit a prescription for a Digihaler product.
Then, physicians can determine if a prescription was filled and
have the option to develop a personalized care plan based on the
data provided.
“As a global leader in generics and biopharmaceuticals, we are
continually striving to improve and innovate around care delivery
to help patients access their medication simply and affordably,”
said Manny Montalvo, SVP, Digital Health & Innovation, Teva
Pharmaceuticals. “With our integrated inhaler we are always looking
for ways to enhance consumer experience as technology evolves, and
Phil’s technology solution will help us build upon our efforts in a
significant and meaningful way.”
“There is incredible opportunity for pharma brands and
physicians to better align outcomes, and Phil’s technology solution
is patient-centric while seamlessly integrating into users’
workflows,” said Deepak Thomas, Founder and Chief Executive
Officer, Phil. “We are pleased to work alongside Teva
Pharmaceuticals to better meet consumers where they are in the
health journey and improve access to medication.”
Learn more about the PhilRx Patient Access Platform.
ProAir Digihaler Indications and Usage
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a
prescription medicine used in people ≥4 years of age for the
treatment or prevention of bronchospasm in people who have
reversible obstructive airway disease and for the prevention of
exercise-induced bronchospasm.
Important Safety Information About ProAir Digihaler
- Contraindications: ProAir Digihaler (albuterol sulfate)
Inhalation Powder is contraindicated in patients with
hypersensitivity to albuterol or patients with a severe
hypersensitivity to milk proteins. Rare cases of hypersensitivity
reactions, including urticaria, angioedema, and rash have been
reported after the use of albuterol sulfate. There have been
reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
- Paradoxical Bronchospasm: ProAir Digihaler can produce
paradoxical bronchospasm that may be life-threatening. Discontinue
ProAir Digihaler and institute alternative therapy if paradoxical
bronchospasm occurs
- Deterioration of Asthma: Need for more doses of ProAir
Digihaler than usual may be a marker of acute or chronic
deterioration of asthma and requires reevaluation of treatment,
such as possible need for anti-inflammatory treatment, e.g.,
corticosteroids
- Use of Anti-Inflammatory Agents: ProAir Digihaler alone
may not be adequate to control asthma in many patients. Early
consideration should be given to adding anti-inflammatory agents,
e.g., corticosteroids
- Cardiovascular Effects: ProAir Digihaler, like other
beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate,
blood pressure, and/or symptoms. If such effects occur, the drug
may need to be discontinued. ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Do Not Exceed Recommended Dose: Fatalities have been
reported in association with excessive use of inhaled
sympathomimetic drugs in patients with asthma
- Hypersensitivity Reactions including Anaphylaxis:
Immediate hypersensitivity reactions may occur after administration
of albuterol sulfate, as demonstrated by rare cases of urticaria,
angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal
edema. Hypersensitivity reactions including anaphylaxis,
angioedema, pruritus, and rash have been reported with the use of
therapies containing lactose, an inactive ingredient in ProAir
Digihaler
- Coexisting Conditions: ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with convulsive disorders, hyperthyroidism, or diabetes mellitus;
and in patients who are unusually responsive to sympathomimetic
amines
- Hypokalemia: As with other beta-agonists, ProAir
Digihaler may produce significant hypokalemia in some patients. The
decrease is usually transient, not requiring supplementation
- Most common adverse reactions (≥1% and >placebo) are
back pain, pain, gastroenteritis viral, sinus headache, urinary
tract infection, nasopharyngitis, oropharyngeal pain and
vomiting
- Drug Interactions: Other short-acting sympathomimetic
bronchodilators should not be used concomitantly with ProAir
Digihaler
- Beta-Blockers: Beta-adrenergic-receptor blocking agents
not only block the pulmonary effect of beta-agonists, such as
ProAir Digihaler, but may produce severe bronchospasm in asthmatic
patients. Therefore, patients with asthma should not normally be
treated with beta-blockers
- Diuretics: Caution is advised in the coadministration of
beta-agonists with non-potassium sparing diuretics (such as loop or
thiazide diuretics). Consider monitoring potassium levels
- Digoxin: Carefully evaluate the serum digoxin levels in
patients who are currently receiving digoxin and ProAir
Digihaler
- Monoamine Oxidase Inhibitors or Tricyclic
Antidepressants: ProAir Digihaler should be administered with
extreme caution to patients being treated with these agents, or
within 2 weeks of discontinuation of these agents, because the
action of albuterol on the cardiovascular system may be
potentiated. Consider alternative therapy
Please see full Prescribing Information for ProAir
Digihaler.
AirDuo Digihaler Indications and Usage
- AirDuo Digihaler is a prescription medicine used to control
symptoms of asthma and to prevent symptoms such as wheezing in
people 12 years of age and older.
- AirDuo Digihaler is not used to relieve sudden breathing
problems from asthma and won't replace a rescue inhaler.
AirDuo Digihaler contains a built-in electronic module that
records and stores information about inhaler events. AirDuo
Digihaler may be used with, and transmits information to, a mobile
App.
AirDuo Digihaler does not need to be connected to the app in
order for you to take your medicine.
Important Safety Information About AirDuo Digihaler
- AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist
(LABA) medicines such as salmeterol when used alone increase the
risk of hospitalizations and death from asthma problems. AirDuo
Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When
an ICS and a LABA are used together, there is not a significant
increased risk in hospitalizations and death from asthma
problems
- Do not use AirDuo Digihaler to treat sudden breathing
problems from asthma. Always have a rescue inhaler with you to
treat sudden symptoms
- Do not use AirDuo Digihaler if you have a severe allergy
to milk proteins or if you are allergic to any of the ingredients
in the product. Ask your healthcare provider if you are not
sure
- Do not use AirDuo Digihaler more often than
prescribed
- Do not take AirDuo Digihaler with other medicines that
contain a LABA for any reason
- Tell your healthcare provider about all the medicines you
take and about all of your health conditions
- AirDuo Digihaler can cause serious side effects,
including:
- Fungal infection in your mouth or throat (thrush). Rinse
your mouth with water without swallowing after using AirDuo
Digihaler to help reduce your chance of getting thrush
- Weakened immune system and increased chance of getting
infections (immunosuppression). You should avoid exposure to
chickenpox and measles, and, if exposed, tell your healthcare
provider right away. Worsening of existing tuberculosis, fungal,
bacterial, viral, or parasitic infections, or herpes infection of
the eye (ocular herpes simplex) may occur
- Reduced adrenal function. This can happen when you stop
taking an oral corticosteroid (such as prednisone) and start taking
a medicine containing an inhaled corticosteroid (such as AirDuo
Digihaler). During this transition period, when your body is under
stress such as from fever, trauma (such as a car accident),
infection, or surgery, adrenal insufficiency can get worse and may
cause death. Symptoms of adrenal insufficiency include:
- feeling tired
- lack of energy
- weakness
- nausea and vomiting
- low blood pressure
- Sudden breathing problems immediately after inhaling your
medicine. If you have sudden breathing problems immediately
after inhaling your medicine, stop using AirDuo Digihaler and call
your healthcare provider right away
- Serious allergic reactions. Stop using AirDuo Digihaler
and call your healthcare provider or get emergency medical care if
you get any of the following symptoms of a serious allergic
reaction:
- rash
- hives
- swelling of your face, mouth, and tongue
- breathing problems
- Effects on heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
- Effects on nervous system
- Bone thinning or weakness (osteoporosis)
- Slowed growth in children. A child's growth should be
checked often
- Eye problems including glaucoma and cataracts. You
should have regular eye exams while using AirDuo Digihaler
- Changes in laboratory blood values (sugar, potassium,
certain types of white blood cells)
- Common side effects of AirDuo Digihaler include:
- Infection of nose and throat (nasopharyngitis)
- thrush in your mouth or throat. Rinse your mouth with water
without swallowing after use to help prevent this.
- back pain
- headache
- cough
- These are not all the possible side effects of AirDuo
Digihaler. Call your healthcare provider for medical advice about
side effects.
- You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see full Prescribing Information for AirDuo
Digihaler.
ArmonAir Digihaler Indications and Usage
ArmonAir® Digihaler® (fluticasone propionate) inhalation powder
is indicated for the maintenance treatment of asthma as
prophylactic therapy in patients 12 years of age and older.
ArmonAir Digihaler contains a built-in electronic module which
detects, records, and stores data on inhaler events for
transmission to mobile App. Use of the App is not required for
administration of medication to the patient.
Important Safety Information for ArmonAir Digihaler
Contraindications: ArmonAir Digihaler is contraindicated
in:
- Primary treatment of status asthmaticus or other acute episodes
of asthma requiring intensive measures
- Patients with known severe hypersensitivity to milk proteins or
any ingredients of ArmonAir Digihaler
- Deterioration of Disease and Acute Episodes: ArmonAir
Digihaler is not indicated for the relief of acute bronchospasm. An
inhaled, short-acting beta2-agonist, not ArmonAir Digihaler, should
be used to relieve acute symptoms such as shortness of breath
- Oropharyngeal Candidiasis has occurred in patients
treated with ArmonAir Digihaler. Advise patients to rinse the mouth
with water without swallowing following inhalation
- Immunosuppression and Risks of Infections: Patients who
use corticosteroids, such as found in ArmonAir Digihaler are at
risk for potential worsening of existing tuberculosis; fungal,
bacterial, viral, or parasitic infections; or ocular herpes
simplex. A more serious or even fatal course of chickenpox or
measles may occur in susceptible patients. Use with caution in
patients with the above because of the potential for worsening of
these infections
- Transferring Patients from Systemic Corticosteroid
Therapy: Particular care is needed for patients who have been
transferred from systemically active corticosteroids to ICS because
deaths due to adrenal insufficiency have occurred in patients with
asthma during and after transfer from systemic corticosteroids to
less systemically available ICS. Taper patients slowly from
systemic corticosteroids if transferring to ArmonAir Digihaler
- Hypercorticism and Adrenal Suppression may occur with
high doses of ICS, including fluticasone propionate, or at the
recommended dose in susceptible individuals. If such changes occur,
discontinue ArmonAir Digihaler slowly
- Drug Interactions with Strong Cytochrome P450 3A4
Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4)
inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler
is not recommended because increased systemic corticosteroid
adverse effects may occur.
- Paradoxical Bronchospasm and Upper Airway Symptoms:
Paradoxical bronchospasm may occur. if bronchospasm occurs treat
immediately with an inhaled, short-acting bronchodilator
discontinue ArmonAir Digihaler and institute alternative
therapy
- Hypersensitivity Reactions, Including Anaphylaxis:
Immediate hypersensitivity reactions (e.g., urticaria, angioedema,
rash, bronchospasm, hypotension), including anaphylaxis, may occur
after administration of ArmonAir Digihaler. Discontinue ArmonAir
Digihaler if such reactions occur
- Reduction in Bone Mineral Density (BMD): Decreases in
BMD have been observed with long-term administration of products
containing ICS. Patients with major risk factors for decreased bone
mineral content, such as prolonged immobilization, family history
of osteoporosis, or chronic use of drugs that can reduce bone mass
(e.g., anticonvulsants, oral corticosteroids) should be monitored
and treated with established standards of care when using ArmonAir
Digihaler
- Effect on Growth: ICS may cause a reduction in growth
velocity. Patients should be maintained on the lowest dose of
inhaled corticosteroid that effectively controls their asthma.
Monitor growth of pediatric patients receiving ArmonAir
Digihaler
- Glaucoma and Cataracts: Long-term use of ICS, including
fluticasone propionate, a component of ArmonAir Digihaler, may
increase the risk for cataracts or glaucoma. Regular eye exams
should be considered
- Eosinophilic Conditions and Churg-Strauss Syndrome:
Systemic eosinophilic conditions, such as Churg-Strauss syndrome,
may occur when using ArmonAir Digihaler. Be alert to eosinophilia,
vasculitic rash, worsening pulmonary symptoms, cardiac
complications, and/or neuropathy
- Adverse Reactions with ArmonAir Digihaler: Most common
adverse reactions (greater than or equal to 3%) are: upper
respiratory tract infection, nasopharyngitis, oral candidiasis,
headache, and cough
Please see full Prescribing Information for ArmonAir
Digihaler.
About Phil, Inc.
Phil, Inc. revolutionizes life science product commercialization
with technology to improve prescription access. Our patient access
platform removes barriers to medication access and ensures patients
can seamlessly start and adhere to therapy. Providing end-to-end
visibility into the prescription life cycle, we unlock coverage and
maximize reimbursement for brands while integrating into the lives
and workflows of patients and providers. We combine a Silicon
Valley mindset and deep pharma expertise with data insights and
software-driven platform customization to improve provider
experience and elevate brand value.
About Teva Pharmaceuticals
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
innovative medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative medicines research and
operations supporting our growing portfolio of innovative medicines
and biopharmaceutical products. Learn more at
www.tevapharm.com.
About Digihaler®
Asthma is caused by chronic inflammation of the lung airways and
causes coughing, chest tightness, wheezing and shortness of breath.
According to the Centers for Disease Control and Prevention (CDC),
over 25 million Americans have asthma. Clinical data demonstrate
the impact of the Digihaler System on asthma management resulting
in a reduction in SABA use and increase in SABA-free days. The
objective data support more timely patient-physician interactions
versus standard of care. Patients may connect their inhaler to an
app, which records inhalation data, and allows patients to securely
share the data with a physician or care team to establish more
personalized treatment plans.
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version on businesswire.com: https://www.businesswire.com/news/home/20230606005187/en/
Media Contact Katie Beach Evoke Canale for Phil
Katherine.Beach@canalecomm.com
PR Contacts Teva Pharmaceuticals Kelley Dougherty,
(973) 832-2810 Yonatan Beker, (973) 264-7378
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