LONDON, Dec. 17, 2020 /PRNewswire/ -- Hikma
Pharmaceuticals PLC (Hikma), the multinational
pharmaceutical company, announces it has received FDA approval for
and launched its generic version of GlaxoSmithKline's Advair
Diskus®1 (Fluticasone Propionate and Salmeterol
Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the
US.
Hikma worked with Vectura Group, a UK based provider of
innovative inhaler drug delivery solutions, to develop the
proprietary dry powder inhaler and formulation technology.
According to IQVIA, US sales of Fluticasone Propionate and
Salmeterol Inhalation Powder USP, 100mcg/50mcg and 250mcg/50mcg,
were approximately $2 billion in the
12 months ending September 2020.
Siggi Olafsson, Chief Executive
Officer of Hikma, said "The approval of our generic version of
Advair Diskus® marks an important milestone in our
strategy to develop more complex respiratory products.
Through the unwavering dedication of our employees and close
collaboration with the Vectura team, we have developed a high
quality and substitutable generic product for Advair
Diskus® that will improve availability of this critical
medicine. We are very pleased to have now launched this
product and will leverage the investments we have made and the
experience we have gained through this process to develop a range
of respiratory and other complex treatment options for patients and
healthcare providers, helping us to continue to put better health,
within reach, every day."
Enquiries
Hikma
Pharmaceuticals PLC
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Susan
Ringdal
EVP, Strategic
Planning and Global Affairs
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+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
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Steve
Weiss
David
Belian
US Communications and
Public Affairs
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+1 732 720 2830/ +1
732 788 8279
+1 732 720 2814/+1
848 254 4875
uscommunications@hikma.com
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Teneo
(Press):
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Charles Armitstead /
Camilla
Cunningham
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+44 (0)7703 330 269/
+44 (0)7464 982 426
|
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC:
HKMPY) (rated BBB-/stable S&P, BBB-/stable Fitch and Ba1/stable
Moody's)
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
more than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we are a global company with a local presence across
the United States (US), the
Middle East and North Africa (MENA) and Europe, and we use our unique insight and
expertise to transform cutting-edge science into innovative
solutions that transform people's lives. We're committed to our
customers, and the people they care for, and by thinking creatively
and acting practically, we provide them with a broad range of
branded and non-branded generic medicines. Together, our 8,600
colleagues are helping to shape a healthier world that enriches all
our communities. We are a leading licensing partner, and through
our venture capital arm, are helping bring innovative health
technologies to people around the world. For more information,
please visit: www.hikma.com
Important Safety Information for Fluticasone
Propionate and Salmeterol Inhalation Powder USP,
100mcg/50mcg, 250mcg/50mcg:
Contraindications
The use of fluticasone propionate
and salmeterol inhalation powder is contraindicated in the
following conditions:
- Primary treatment of status asthmaticus or other acute episodes
of asthma or chronic obstructive pulmonary disease (COPD) where
intensive measures are required.
- Severe hypersensitivity to milk proteins or demonstrated
hypersensitivity to fluticasone propionate, salmeterol or any of
the excipients.
Warnings and Precautions
Warnings While Using This Medicine:
Tell your doctor
if you are pregnant or breastfeeding, or if you have liver disease,
cataracts, diabetes, glaucoma, heart disease, high blood pressure,
heart rhythm problems, thyroid problems, seizures, or osteoporosis.
Tell your doctor about any immune system problems or infections,
including herpes simplex in your eye, tuberculosis, or parasites.
Tell your doctor if you have been exposed to chickenpox or
measles.
This medicine may cause the following
problems:
Increased risk of asthma-related hospital stays,
intubations, and death
Increased trouble breathing right after use (paradoxical
bronchospasm)
Increased risk of pneumonia in people who have COPD
Increased risk of infection, including fungus infection in the
mouth (thrush)
Low bone mineral density, which may lead to osteoporosis
Cataracts, glaucoma, or other vision problems
Slow growth in children
Adrenal gland problems
This medicine will not stop an asthma attack that has already
started. You should have another medicine to use in case of an
acute asthma attack or COPD flare-up. Tell your doctor right away
if your condition gets worse or you need to use your other medicine
more often than usual.
If any of your asthma medicines do not seem to be working as well
as usual, call your doctor right away. Do not change your doses or
stop using your medicines without asking your doctor.
Tell any doctor or dentist who treats you that you are using this
medicine.
Call your doctor if your symptoms do not improve or if they get
worse.
Your doctor will check your progress and the effects of this
medicine at regular visits. Keep all appointments.
Keep all medicine out of the reach of children. Never share your
medicine with anyone.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side
effects:
Allergic reaction: Itching or hives, swelling in your face or
hands, swelling or tingling in your mouth or throat, chest
tightness, trouble breathing
Changes in skin color, dark freckles, easy bruising, muscle
weakness, round or puffy face
Chest pain, trouble breathing
Dry mouth, increased thirst, muscle cramps, nausea, vomiting
Eye pain or trouble seeing
Fast, pounding, or uneven heartbeat
Fever, chills, cough, runny or stuffy nose, sore throat, body
aches
Tremors, nervousness, or shaking
Unusual tiredness or weakness
Worsening of breathing problems
If you notice these less serious side effects, talk with your
doctor:
Headache
Hoarseness, voice changes
White patches inside the mouth or throat
If you notice other side effects that you think are caused by
this medicine, tell your doctor.
Fluticasone propionate and salmeterol inhalation powder contains
salmeterol. Long-acting beta2-adrenergic agonist (LABA)
medicines such as salmeterol when used alone increase the risk of
hospitalizations and death from asthma problems. Fluticasone
propionate and salmeterol inhalation powder contains an inhaled
corticosteroid (ICS) and a LABA. When a fixed-dise
combination ICS and a LABA are used together, there is not a
significant increased risk in hospitalizations and death from
asthma problems compared with ICS alone.
Do not use other medicines that contain a LABA for any reason.
Ask your healthcare provider or pharmacist if any of your other
medicines are LABA medicines.
Do not use fluticasone propionate and salmeterol inhalation
powder to relieve sudden breathing problems. Always have a rescue
inhaler with you to treat sudden symptoms.
Do not use fluticasone propionate and salmeterol inhalation
powder if you have a severe allergy to milk proteins. Ask your
healthcare provider if you are not sure.
Do not use fluticasone propionate and salmeterol inhalation
powder if you are allergic to fluticasone propionate, salmeterol or
any of the ingredients in fluticasone propionate and salmeterol
inhalation powder. Ask your healthcare provider if you are not
sure.
Do not use fluticasone propionate and salmeterol inhalation
powder more often or at a higher dose than prescribed.
Rinse your mouth with water without swallowing after each dose
of fluticasone propionate and salmeterol inhalation powder.
Call your healthcare provider or get medical care right away
if:
- your breathing problems get
worse or you need to use your rescue inhaler more often than
usual.
- your rescue inhaler does not
work as well to relieve your symptoms.
- you need to use 4 or more
inhalations of your rescue inhaler in 24 hours for 2 or more days
in a row.
- you use 1 whole canister of
your rescue inhaler in 8 weeks.
- your peak flow meter results
decrease. Your healthcare provider will tell you the numbers that
are right for you.
- you have asthma and your
symptoms do not improve after using regularly for 1 week
Fluticasone propionate and salmeterol inhalation powder can
cause serious side effects, including:
- Fungal infection in your mouth or throat (thrush). Rinse
your mouth with water without swallowing after each dose of
fluticasone propionate and salmeterol inhalation powder.
- Pneumonia. People with COPD have a greater chance of
getting pneumonia. Fluticasone propionate and salmeterol inhalation
powder may increase this risk. Call your healthcare provider right
away if you have an increase in mucus (sputum) production, change
in mucus color, fever, chills, increased cough or increased
breathing problems.
- Weakened immune system and greater chance of getting
infections (immunosuppression). Fluticasone propionate and
salmeterol inhalation powder may make you more prone to infection.
Chickenpox and measles, for example, can have a more serious or
even fatal course in children or adults using corticosteroids.
- Reduced adrenal function (adrenal insufficiency). This
can happen when you stop taking oral corticosteroid medicines (like
prednisone) and start taking a medicine containing an inhaled
steroid (like fluticasone propionate and salmeterol inhalation
powder). During this transition period, when your body is under
stress such as fever, trauma, infection, surgery or more severe
COPD symptoms, adrenal insufficiency can get worse and may cause
death. Symptoms of adrenal insufficiency include feeling tired,
lack of energy, weakness, nausea and vomiting and low blood
pressure.
- Sudden breathing problems immediately after inhaling your
medicine. If you have sudden breathing problems immediately
after inhaling your medicine, stop using fluticasone propionate and
salmeterol inhalation powder and call your healthcare provider
right away.
- Serious allergic reactions. Call your healthcare
provider or get emergency medical care right away if you have any
of the following symptoms of a serious allergic reaction: rash;
hives; swelling of the mouth, face and/or tongue; breathing
problems.
- Effects on the heart. Call your healthcare provider if
you have an increase in blood pressure, fast or irregular heartbeat
or chest pain.
- Effects on the nervous system. Call your healthcare
provider if you have tremor or nervousness.
- Bone thinning or weakness (osteoporosis). Get regular
bone density screenings if you have or are at risk for osteoporosis
treated with established standards of care.
- Slowed growth in children. Have your child's growth
checked regularly by a healthcare provider while using fluticasone
propionate and salmeterol inhalation powder.
- Eye problems. Tell your healthcare provider if you have
glaucoma, increased pressure in your eye, cataracts or other
changes in vision. Get regular eye exams while using fluticasone
propionate and salmeterol inhalation powder.
- Changes in laboratory blood levels (sugar, potassium,
certain types of white blood cells). Get blood tests at your
healthcare provider's recommendation.
Common Side Effects
- Common side effects for asthma include upper respiratory
tract infection, throat irritation, hoarseness and voice changes,
thrush in your mouth or throat, bronchitis, cough, headache, and
nausea and vomiting. In children with asthma, infections in the
ear, nose, and throat are common.
- Common side effects for COPD include thrush in your
mouth or throat, throat irritation, hoarseness and voice changes,
viral respiratory infections, headache, and muscle and bone
pain.
Common side effects of fluticasone propionate and salmeterol
inhalation powder in patients with COPD include thrush in the mouth
or throat, throat irritation, hoarseness and voice changes, viral
respiratory infections, headache and muscle and bone pain.
These are not all the possible side effects of fluticasone
propionate and salmeterol inhalation powder. Call your healthcare
provider for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
Drug Interactions
Tell your healthcare provider about
all of your medical conditions and about all the medicines you
take, as fluticasone propionate and salmeterol inhalation powder
can interact with other medicines and may cause side effects, in
some cases severe:
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine,
including over-the-counter medicines, vitamins, and herbal
products.
Some foods and medicines can affect how fluticasone/salmeterol
works. Tell your doctor if you are using any of the following:
Blood pressure medicine
Diuretic (water pill)
Medicine to treat depression or an MAO inhibitor within the past 2
weeks (including nefazodone)
Medicine to treat HIV or AIDS (including atazanavir, indinavir,
nelfinavir, ritonavir, saquinavir)
Medicine to treat an infection (including clarithromycin,
itraconazole, ketoconazole, telithromycin)
Seizure medicine
Pregnancy and Breastfeeding
Tell your healthcare
provider if you are pregnant, plan to become pregnant or are
breastfeeding.
Dosage and Administration
Fluticasone propionate and
salmeterol inhalation powder should be administered as 1 inhalation
twice daily by the orally inhaled route only. After inhalation, the
patient should rinse his/her mouth with water without swallowing to
help reduce the risk of oropharyngeal candidiasis.
More frequent use or taking more than 1 inhalation twice daily
of the prescribed strength of fluticasone propionate and salmeterol
inhalation powder is not recommended.
Do not use additional LABA for any reason.
Indications and Usage
Treatment of
Asthma
Fluticasone propionate and salmeterol inhalation
powder is indicated for the twice-daily treatment of asthma in
patients aged 4 years and older.
Important Limitation of Use:
Fluticasone propionate
and salmeterol inhalation powder is NOT indicated for the relief of
acute bronchospasm.
Maintenance Treatment of COPD
Fluticasone propionate
and salmeterol inhalation powder 250 mcg/50 mcg is indicated for
the twice-daily maintenance treatment of airflow obstruction in
patients with COPD, including chronic bronchitis and/or emphysema.
Fluticasone propionate and salmeterol inhalation powder 250 mcg/50
mcg is also indicated to reduce exacerbations of COPD in patients
with a history of exacerbations.
Important Limitation of Use:
Fluticasone propionate and salmeterol inhalation powder is NOT
indicated for the relief of acute bronchospasm.
For more information about fluticasone propionate and
salmeterol inhalation powder, please see the full Prescribing
Information and Medication Guide, which you can find in the full
press release published on our website at
https://www.hikma.com/newsroom/#pageRS=1.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit https://www.fda.gov/medwatch
or call 1-800-FDA-1088.
Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228
Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley
Heights, NJ, 07922
Document identification number: WW40040
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1 Advair® and Advair
Diskus® are registered trademarks of GSK group of
companies.
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SOURCE Hikma Pharmaceuticals USA Inc.