Taro Launches Specialty Generic Deferiprone Tablets, 500mg in the U.S.
September 28 2020 - 01:01PM
Business Wire
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro” or “the
Company”) today announced the launch of a new specialty generic,
deferiprone, an iron chelator indicated for the treatment of
patients with transfusional iron overload due to thalassemia
syndromes when current chelation therapy is inadequate. Deferiprone
is the generic version of Ferriprox®. This product expands Taro’s
capabilities to include specialty products.
Thalassemia syndromes are relatively rare in the United States,
but are one of the most common autosomal recessive disorders in the
world. The incidence of symptomatic cases is estimated to be
approximately 1 in 100,000 individuals in the general
population.¹
At launch, Taro’s deferiprone tablets will be exclusively
dispensed by BioPlus® Specialty Pharmacy. For more information,
visit Taro Cares at www.tarocares.com or call 1-888-292-0744.
Indication
Deferiprone is an iron
chelator indicated for the treatment of patients with transfusional
iron overload due to thalassemia syndromes when current chelation
therapy is inadequate.
Approval is based on a
reduction in serum ferritin levels. There are no controlled trials
demonstrating a direct treatment benefit, such as improvement in
disease-related symptoms, functioning, or increased
survival.
Limitations of Use: Safety and
effectiveness have not been established for the treatment of
transfusional iron overload in patients with other chronic
anemias.
Important Safety Information
WARNING:
AGRANULOCYTOSIS AND NEUTROPENIA
■ Deferiprone can cause agranulocytosis that
can lead to serious infections and death. Neutropenia may precede
the development of agranulocytosis.
■ Measure the absolute neutrophil count (ANC)
before starting deferiprone and monitor the ANC weekly while on
therapy.
■ Interrupt deferiprone if infection develops
and monitor the ANC more frequently.
■ Advise patients taking deferiprone to report
immediately any symptoms indicative of infection.
Deferiprone is contraindicated in patients with known
hypersensitivity to deferiprone or to any of the excipients in the
formulation.
Deferiprone can cause fetal harm. Women should be advised of the
potential hazard to the fetus and to avoid pregnancy while on this
drug. Advise females of reproductive potential to use an effective
method of contraception during treatment with deferiprone and for
at least six months after the last dose. Advise males with female
partners of reproductive potential to use effective contraception
during treatment with deferiprone and for at least three months
after the last dose. Advise females not to breastfeed during
treatment with deferiprone and for at least 2 weeks after the last
dose.
Avoid co-administration of
deferiprone with other drugs known to be associated with
neutropenia or agranulocytosis; however, if this is unavoidable,
closely monitor the absolute neutrophil count. Avoid
co-administration with UGT1A6 inhibitors. Allow at least a 4-hour
interval between administration of deferiprone and drugs or
supplements containing polyvalent cations (e.g., iron, aluminum, or
zinc).
The most common adverse
reactions are (incidence ≥5%) nausea, vomiting and abdominal pain,
alanine aminotransferase increased, arthralgia, and
neutropenia.
Inform patients that their
urine might show a reddish/brown discoloration due to the excretion
of iron. This is a very common sign of the desired effect, and it
is not harmful.
Please see full Prescribing Information, including boxed WARNING
and Medication Guide.
¹ Source:
https://rarediseases.org/rare-diseases/thalassemia-major/#:~:text=Beta%20thalassemia%20is%20relatively%20rare,individuals%20in%20the%20general%20population
About Taro
Taro Pharmaceutical Industries Ltd. is a multinational,
science-based pharmaceutical company, dedicated to meeting the
needs of its customers through the discovery, development,
manufacturing and marketing of the highest quality healthcare
products. For further information on Taro Pharmaceutical Industries
Ltd., please visit the Company’s website at www.taro.com.
Safe Harbor Statement
Certain statements in this release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited
to, statements that do not describe historical facts or that refer
or relate to events or circumstances the Company “estimates,”
“believes,” or “expects” to happen or similar language, and
statements. Although the Company believes the expectations
reflected in such forward-looking statements to be based on
reasonable assumptions, it can give no assurances that its
expectations will be attained. Forward-looking statements are
applicable only as of the date on which they are made.
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version on businesswire.com: https://www.businesswire.com/news/home/20200928005649/en/
Daphne Huang VP, CFO (914) 345-9001
Daphne.Huang@taro.com
William J. Coote AVP, Treasurer and Investor Relations
(914) 345-9001 William.Coote@taro.com
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