TIDMHIK
RNS Number : 0788J
Hikma Pharmaceuticals Plc
17 December 2020
London, 17 December 2020 - Hikma Pharmaceuticals PLC (Hikma),
the multinational pharmaceutical company, annou nces it has
received FDA approval for and launched its generic version of
GlaxoSmithKline's Advair Diskus(R)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(R) 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(R) 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."
(1) Advair(R) and Advair Diskus(R) are registered trademarks of
GSK group of companies.
-S -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
Steve Weiss +1 732 720 2830/ +1 732 788
David Belian 8279
US Communications and Public Affairs +1 732 720 2814/+1 848 254 4875
uscommunications@hikma.com
Teneo (Press):
Charles Armitstead / Camilla Cunningham +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 beta(2) -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. o 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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