TOFA AD Ointment 15g

Introduction About TOFA AD OINTMENT

TOFA AD OINTMENT is used to manage mild to moderate atopic dermatitis (AD), such
as dry, itchy, swollen, and red skin. It contains Tofacitinib, which belongs to
the group of medicines called Janus Kinase Inhibitors. It suppresses an
overactive immune system by inhibiting certain enzymes called Janus kinases
(JAKs). Thus, TOFA AD OINTMENT blocks the production of pro-inflammatory
substances (including cytokines) that contribute to the development of
inflammation and other symptoms of atopic dermatitis.

Apply TOFA AD OINTMENT to the affected area as directed by your doctor to get
the most benefit. Prior to the initiation of this medicine, your doctor may
order blood tests to understand and monitor your existing condition.

TOFA AD OINTMENT is not recommended for use in pregnant women and breastfeeding
women. Consult your doctor before using it.

TOFA AD OINTMENT is not recommended for use if you have active tuberculosis (TB)
or severe liver disease. Consult your doctor before using it.

TOFA AD OINTMENT should be used with caution in patients with a history of
chronic lung disease or in those who develop interstitial lung disease due to
the increased risk of infections. Consult your doctor before using it.

The safety and efficacy of TOFA AD OINTMENT in children are not established.
Consult your child’s doctor for advice.

The most common side effects of using TOFA AD OINTMENT are application site
eczema, application site itching, and fever. Consult your doctor if any of the
side effects worsen.

Uses Of TOFA AD OINTMENT

It is used to:

• manage mild to moderate atopic dermatitis

How TOFA AD OINTMENT Works

TOFA AD OINTMENT suppresses an overactive immune system by inhibiting certain
enzymes called Janus kinases (JAKs). Thus, TOFA AD OINTMENT blocks the
production of pro-inflammatory substances (including cytokines) that contribute
to the development of inflammation and other symptoms of atopic dermatitis.

How to use TOFA AD OINTMENT

Apply TOFA AD OINTMENT as advised by your doctor. It is for external use only.
Apply TOFA AD OINTMENT as a thin layer to the affected area as directed by your
doctor to get the most benefit. Your doctor will decide the correct dose and
duration of TOFA AD OINTMENT for you depending upon your age, body weight, and
disease condition.

Overdose

If you or anyone else accidentally swallows too much of TOFA AD OINTMENT,
consult your doctor immediately or visit the nearby hospital.

Side Effects Of TOFA AD OINTMENT

Common side effects of TOFA AD OINTMENT:

• Application site eczema
• Application site itching
• Fever

Stop taking TOFA AD OINTMENT and contact your physician immediately if you experience any of the following side effects:

• Serious infection, an opportunistic infection, or sepsis
• Serious allergic reactions such as urticaria and angioedema
• Signs of myocardial infarction or stroke

How To Manage Side Effects

!### Skin rash Or Itching

Keep the affected area clean and dry and avoid scratching to prevent further
irritation or infection. Apply calamine lotion to help reduce itching and
inflammation. Applying cool compresses and wearing loose, breathable clothing
can also provide relief. If the itching persists, consult your doctor.

Warning & Precautions

!### Pregnancy

ContraindicatedTOFA AD OINTMENT is not recommended for use by pregnant women. Women of
childbearing potential should be advised to use effective contrace
management with TOFA AD OINTMENT and for at least 4 weeks after the last dose.
Consult your doctor before using it.

!### Breastfeeding

ContraindicatedTOFA AD OINTMENT is not recommended for use by breastfeeding women. Consult your
doctor before using it.

!### Driving and Using Machines

Use with CautionTOFA AD OINTMENT has no influence on the ability to drive or operate machinery.

!### Liver

ContraindicatedTOFA AD OINTMENT is not recommended for use if you have severe liver disease.
Consult your doctor before using it.

!### Allergy

ContraindicatedDo not use TOFA AD OINTMENT if you are allergic to tofacitinib or any of the
other ingredients in this medicine.

!### Lungs

Consult your doctorTOFA AD OINTMENT is not recommended for use if you have active tuberculosis
(TB). It should be used with caution in patients with a history of chronic lung
disease or in those who develop interstitial lung disease due to the increased
risk of infections. Consult your doctor before using it.

!### Use In Pediatrics

Consult your doctorThe safety and efficacy of TOFA AD OINTMENT in children are not established.
Consult your child’s doctor for advice.

Other Warnings for TOFA AD OINTMENT

Before using TOFA AD OINTMENT, inform your doctor if you:

• Have a chronic or recurrent infection
• Have been exposed to tuberculosis
• History of a serious or an opportunistic infection
• Have resided or travelled in areas of endemic tuberculosis or endemic mycoses
• Have underlying conditions that may predispose to infections
• Have a decrease in white blood cell count
• Have herpes zoster (due to virus reactivation)
• Have an increased risk of thrombosis (blood clots)

Who should not take TOFA AD OINTMENT

TOFA AD OINTMENT is not recommended for use if you:

• Have serious infections, such as sepsis, or opportunistic infections
• Have a low white blood cell count
• Have low levels of haemoglobin

Drug - Drug interaction

• Antifungals (Ex. ketoconazole, fluconazole)
• Anti-tubercular agent (Ex. rifampicin)
• Immunosuppressants (Ex. tacrolimus, ciclosporin)
• Live vaccines

Synopsis

Drug	Tofacitinib
Pharmacological Category	Janus Kinase Inhibitors
Therapeutic Indication	Atopic dermatitis
Dosage Forms	Tablet, Capsule, Gel, and Ointment

More Information

Storage

• Keep TOFA AD OINTMENT out of reach of children
• Store at room temperature not exceeding 30ºC. Do not freeze

Useful Diagnostic Tests

• Complete Blood Count (CBC)