Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Drug Interactions and Decreased Vitamin
Absorption
(Additions and/or
revisions underlined)
XENICAL
may interact with concomitant drugs including cyclosporine, levothyroxine,
warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs [see
Drug Interactions (7)].
Data
from a XENICAL and cyclosporine drug interaction study indicate a reduction in
cyclosporine plasma levels when XENICAL was coadministered with cyclosporine.
Therefore, XENICAL and cyclosporine should not be simultaneously
coadministered. To reduce
the chance of a drug-drug
interaction, cyclosporine should
be taken at least 3 hours before
or after XENICAL in patients taking both drugs. In addition, in those patients whose cyclosporine levels
are being measured, more
frequent monitoring should be considered.
Patients
should be strongly encouraged to take a multivitamin supplement that contains
fat-soluble vitamins to ensure adequate nutrition because XENICAL has been
shown to reduce the absorption of some fat-soluble vitamins and beta- carotene [see
Dosage and Administration (2), and Adverse
Reactions (6.1)]. In addition, the levels of vitamin D and beta-
carotene may be low in obese patients compared with non-obese subjects. The
supplement should be taken once a day at least 2 hours before or after the
administration of XENICAL, such as at bedtime.
5.3 Oxalate Nephrolithiasis and Oxalate Nephropathy with Renal Failure
(Additions
and/or revisions underlined)
Some patients may develop increased levels of urinary oxalate
following treatment with XENICAL. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function when prescribing XENICAL to patients at increased risk for oxalate nephropathy, including patients
with renal impairment and in those with
a history of hyperoxaluria or calcium oxalate nephrolithiasis. Discontinue
XENICAL in patients who develop oxalate nephropathy.
6
Adverse Reactions
6.1 CLINICAL TRIALS
(Additions and/or
revisions underlined)
Table 4 illustrates the percentage of adult patients
on XENICAL and placebo
who developed a low vitamin
level on two or
more consecutive visits during 1 and 2 years of therapy in studies in which patients
were not previously receiving vitamin supplementation.
…
Table 5 illustrates
the percentage of adolescent patients on XENICAL and placebo who developed a
low vitamin level on two or more consecutive visits during the 1-year study.
6.2 Postmarketing Experience
(Additions and/or
revisions underlined)
The
following adverse reactions have been identified during postapproval use of
XENICAL. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency
or establish a causal relationship to XENICAL exposure.
…
· Acute
oxalate nephropathy and hyperoxaluria after treatment with XENICAL have
been reported in patients with or at risk for renal disease.
7
Drug Interactions
7.2 Fat-soluble Vitamin
Supplements and Analogues
(Additions and/or
revisions underlined)
Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with
XENICAL. XENICAL inhibited absorption
of a vitamin E acetate supplement. The effect of XENICAL on the absorption of
supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not
known at this time [see Clinical Pharmacology (12.3),
and Warnings and Precautions (5.1)].
7.4
Anticoagulants including Warfarin
(Additions and/or
revisions underlined)
Vitamin
K absorption may be decreased with XENICAL. Reports of decreased prothrombin, increased INR and unbalanced
anticoagulant treatment resulting in change of hemostatic parameters have been
reported in patients treated concomitantly with XENICAL
and anticoagulants. Patients
on chronic stable
doses of warfarin
or other anticoagulants who are prescribed XENICAL should be monitored closely for
changes in coagulation parameters [see Clinical Pharmacology (12.3)].
7.7 Antiretroviral Drugs
(Newly Added Subsection)
Loss of virological control has been reported in HIV-infected patients
taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir,
tenofovir disoproxil fumarate, emtricitabine, and with the combinations
lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. The exact mechanism for this is unclear,
but may include a drug-drug interaction that inhibits systemic absorption of
the antiretroviral drug. HIV RNA
levels should be frequently monitored in patients
who take XENICAL
while being treated
for HIV infection. If there is a confirmed increase in HIV viral load,
XENICAL should be discontinued.
8
Use in Specific Populations
8.4 Pediatric Use
(Additions and/or
revisions underlined)
Safety and effectiveness in pediatric patients
below the age of 12 have not been established.
The safety
and efficacy of XENICAL have been evaluated
in obese adolescent patients aged 12 to 16 years. Use of XENICAL in this age group is supported by evidence from adequate and well-controlled studies
of XENICAL in adults with additional
data from a 54-week efficacy and safety study and a 21-day mineral balance
study in obese adolescent patients aged 12 to
16 years. Patients
treated with XENICAL
in the 54-week efficacy and safety study
(64.8% female, 75% Caucasians, 18.8% Blacks, and 6.3% Other) had a mean reduction in BMI of 0.55 kg/m2 compared with an average increase of 0.31
kg/m2 in placebo-treated patients (p=0.001). In both adolescent studies, adverse effects
were generally similar to those
described in adults and included fatty/oily stool, oily spotting, and oily
evacuation. In a subgroup of 152 XENICAL and 77 placebo patients from the 54-week
study, changes in body composition measured by DEXA were similar
in both treatment groups with
the exception of fat mass, which was significantly reduced in patients treated
with XENICAL compared to patients treated with placebo (-2.5 kg vs -0.6 kg, p=0.033). Because XENICAL can interfere with the absorption
of fat-soluble vitamins, all patients should take a daily multivitamin that
contains vitamins A, D, E, K, and beta-carotene. The vitamin supplement should
be taken at least 2 hours before or after XENICAL [see Dosage and
Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or
revisions underlined)
See FDA-approved patient labeling (Patient
Information)
Information for Patients
Patients
should not take XENICAL if they are pregnant, have chronic malabsorption
syndrome, cholestasis or hypersensitivity to XENICAL or to any component of
this product [see Contraindications (4)].
Concomitant Medications
Patients should
be asked if they are taking cyclosporine, beta-carotene or vitamin
E supplements, levothyroxine, warfarin, antiepileptic drugs, amiodarone, or antiretroviral
drugs due to potential interactions [see Drug Interactions (7)].
Patient Information XENICAL (zen i-cal) (orlistat) Capsules
(Additions and/or
revisions underlined)
Read this Patient Information before you
start taking XENICAL and each time you get a refill. There may be new
information. This information does not take the place of talking to your doctor
about your medical condition or your treatment.
What is
XENICAL?
XENICAL is a prescription medicine used
with a low calorie diet to increase weight loss in people with obesity. XENICAL
may help obese people lose weight and keep the weight off.
It is not known if XENICAL is safe and effective in children under 12 years old.
Who should not take XENICAL? Do not take XENICAL if you:
· are pregnant. A minimum weight
gain, and no weight loss, is currently
recommended
for all pregnant women,
including those who are already
overweight or obese.
· always have problems absorbing food (chronic malabsorption)
· have gallbladder problems (cholestasis)
· are allergic
to orlistat or any of the ingredients in XENICAL. See the end of this leaflet for a complete list of
ingredients in XENICAL
What should
I tell my doctor before
taking XENICAL? Before you
take XENICAL, tell your doctor if you
· have liver problems
· have kidney
problems
· have problems
with your thyroid
· have eating problems such as anorexia
or bulimia
· have diabetes
· have a seizure disorder
(epilepsy)
· have an abnormal heart rhythm (arrhythmia)
· have the human immunodeficiency virus (HIV)
Tell your doctor about
all the medicines you take, including prescription
and over- the-counter medicines, vitamins, and herbal supplements.
XENICAL and other medicines may affect
each other causing side effects. XENICAL may affect the way other medicines
work, and other medicines may affect the way XENICAL works.
Especially tell your doctor if you are taking:
· cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
· beta-carotene or vitamin E
supplements
· levothyroxine (Levo-T,
Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl,
Novothyrox, Synthroid, Tirosint, Unithroid).
·
warfarin
(Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)
· amiodarone (Cordarone, Pacerone)
· medicines
used to treat seizures. They may
not work as well while you take XENICAL. Talk to your doctor right away if
your seizures happen more often or get worse while you take XENICAL.
· antiretroviral medicines used to treat HIV. They may not work as well while you take XENICAL.
Know the medicines you take. Keep a list
of your medicines and show it to your doctor and pharmacist when you get a new
medicine.
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