Xtane (Generic Exemestane Tablets)

Xtane (Generic Exemestane Tablets)
© The Swiss Pharmacy

Xtane (Generic Exemestane Tablets) is an aromatase inhibitor
which is used for the treatment of hormone dependent early
breast cancer in postmenopausal women after they have
completed 2 to 3 years of treatment with the medicine
Tamoxifen Citrate and are switched to Xtane tablets for
completion of a total of five consecutive years of adjuvant
hormonal therapy.
It is also used for the treatment of advanced breast cancer
in postmenopausal women whose disease has progressed
following Tamoxifen Citrate (Tamodex Tablets) therapy.

Xtane Tablets are manufactured by
Natco Pharma Limited, India in the
strength of 25 mg.

Chemical Structure - Exemestane

The active ingredient contained in Xtane
tablets is Exemestane.
Each Xtane tablet contains 25 mg of
Exemestane.

Uses of Xtane 25 mg tablets:
Adjuvant Treatment of Postmenopausal Women:
Xtane (Generic Exemestane Tablets) is indicated for adjuvant
treatment of postmenopausal women (women who no longer have
their menstrual periods, either naturally due to their age (after
menopause) or because they have had their ovaries surgically
removed) with estrogen-receptor positive early breast cancer who
have received two to three years of Tamoxifen Citrate (Tamodex
Tablets) and are switched to Exemestane tablets for completion of
a total of five consecutive years of adjuvant hormonal therapy.

Uses of Xtane 25 mg Tablets:
Advanced Breast Cancer in Postmenopausal Women:
Xtane (Generic Exemestane Tablets) is indicated for the treatment
of advanced breast cancer in postmenopausal women whose
disease has progressed following Tamoxifen therapy.
Efficacy has not been demonstrated in patients with oestrogen
receptor negative status.

Recommended Adult Dosage
For most patients, the recommended dose of
Xtane (Generic Exemestane Tablets) is One 25 mg tablet
once daily after a meal for the following indications.
1)Adjuvant treatment of postmenopausal women with
estrogen-receptor positive early breast cancer who have
received two to three years of Tamoxifen Citrate (Tamodex
Tablets) and are switched to Xtane 25mg for completion of a
total of five consecutive years of adjuvant hormonal therapy.

Recommended Adult Dosage
2)The treatment of advanced breast cancer in
postmenopausal women whose disease has
progressed following Tamoxifen Citrate (Tamodex
Tablets) therapy.

Contraindications
➔
Xtane is contraindicated in patients with a known
hypersensitivity to Exemestane or any component of the
tablet.
➔
Administration of Xtane is contraindicated to women of
premenopausal endocrine status, including pregnant
women.

Storage Instructions
Xtane (Generic Exemestane Tablets) have to be
stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Reductions in bone mineral density (BMD) over time are seen with
Exemestane use. During adjuvant treatment with Exemestane, women
with osteoporosis or at risk of osteoporosis should have their bone
mineral density formally assessed by bone densitometry at the
commencement of treatment. Monitor patients for bone mineral density
loss and treat as appropriate.
Routine assessment of 25-hydroxy vitamin D levels prior to the start of
aromatase inhibitor treatment should be performed, due to the high
prevalence of vitamin D deficiency in women with early breast cancer
(EBC). Women with vitamin D deficiency should receive
supplementation with vitamin D.

Warnings
In patients with early breast cancer, the incidence of hematological
abnormalities of Common Toxicity Criteria (CTC) grade 1 or more was
lower in the Exemestane treatment group, compared with Tamoxifen.
Exemestane should not be co-administered with estrogen-containing
agents as these could interfere with its pharmacologic action.
Exemestane is not indicated for the treatment of breast cancer in
premenopausal women.
Exemestane tablets contain sucrose and should not be administered to
patients with rare hereditary problems of fructose intolerance, glucose-
galactose malabsorption or sucrase-isomaltase insufficiency.

Warnings
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential risk to a fetus and to use effective
contraception.
Exemestane tablets contain methyl parahydroxybenzoate which may cause
allergic reactions (possibly delayed).

Alcohol and Xtane Tablets
This medication may make you dizzy or tired. Alcohol or
marijuana (cannabis) can make you more dizzy.
Do not drive, use machinery, or do anything that needs
alertness until you can do it safely.
Limit alcoholic beverages. Talk to your doctor if you are using
marijuana (cannabis).

Drug Interactions
The following interactions have been selected on the basis of their
potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not
recommended, but may be required in some cases. If both medicines are
prescribed together, your doctor may change the dose or how often you
use one or both of the medicines. The medicines are:
Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenytoin,
Primidone, Rifabutin, Rifampin, Rifapentine and St John's Wort.
Certain medicines should not be used at or around the time of eating food
or eating certain types of food since interactions may occur. Using alcohol
or tobacco with certain medicines may also cause interactions to occur.

Possible Side Effects
In the adjuvant treatment of early breast cancer, the most common side
effects occurring in 10% or more of patients in any treatment group
(Exemestane vs. Tamoxifen) were mild to moderate hot flushes (21.2% vs.
19.9%), fatigue (16.1% vs. 14.7%), arthralgia (14.6% vs. 8.6%), headache
(13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating
(11.8% vs. 10.4%).
Discontinuation rates due to adverse events were similar between
Exemestane (Xtane Tablets) and Tamoxifen (Tamodex Tablets) (6.3% vs.
5.1%). Incidences of cardiac ischemic events (myocardial infarction,
angina, and myocardial ischemia) were Exemestane 1.6%, Tamoxifen
0.6%.
Incidence of cardiac failure: Exemestane 0.4%, Tamoxifen 0.3%.

Possible Side Effects
In the treatment of advanced breast cancer, the most
common side effects were mild to moderate and included
hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8%
vs. 10%), increased sweating (4% vs. 8%), and increased
appetite (3% vs. 6%) for exemestane and megestrol acetate,
respectively.

Xtane Tablets Overdosage
Clinical trials have been conducted with Exemestane tablets
given as a single dose to healthy female volunteers at doses as
high as 800 mg and daily for 12 weeks to postmenopausal
women with advanced breast cancer at doses as high as 600
mg. These dosages were well tolerated.
There is no specific antidote to Xtane tablets overdosage and
treatment must be symptomatic. General supportive care,
including frequent monitoring of vital signs and close
observation of the patient, is indicated.

Xtane Tablets During Pregnancy
Exemestane (Xtane tablets) has been classified by the US FDA as
pregnancy category X. There are no studies in pregnant women using
Exemestane. Exemestane (Xtane tablets) is indicated for postmenopausal
women. Exemestane can cause fetal harm when administered to a
pregnant woman.
Limited human data from case reports are insufficient to inform a drug-
associated risk. In animal reproduction studies, administration of
exemestane to pregnant rats and rabbits caused increased incidence of
abortions, embryo-fetal toxicity, and prolonged gestation with abnormal or
difficult labor.
Advise pregnant women of the potential risk to a fetus.

Xtane Tablets are manufactured by Natco
Pharma Limited, India.
For More details Click Here

Xtane (Generic Exemestane Tablets)

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