Adaly 40mg Injection 0.8ml

Introduction About ADALY 40MG INJECTION

ADALY 40MG INJECTION contains Adalimumab which belongs to the group of medicines
called a Disease modifying antirheumatic drugs (DMARDs). It is used to manage
severe joint pain and inflammation (Ex. rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic
arthritis). It can also be used to manage other bone conditions such as
ankylosing spondylitis (back pain) and axial spondyloarthritis (pain in bones of
your head, neck, back and chest).

It also helps in managing auto-immune conditions such as plaque psoriasis (dry,
itchy, scaly patches on the skin), hidradenitis suppurativa (painful skin
condition causing abscess and scarring), inflammatory bowel disease (such as
Crohn’s disease and Ulcerative colitis) and eye inflammation (non-infective
uveitis).

Before receiving ADALY 40MG INJECTION, inform your doctor if you have any lung,
liver, kidney or heart problems. You must also inform your doctor if you have
any breathing problems (COPD), have an habit of smoking, recently received any
vaccination, recently visited some one who has a serious infection or live in an
infection prone as a precaution.

ADALY 40MG INJECTION is strictly not recommended for use in patients with an
active infection (Ex. tuberculosis) or heart failure. Inform your doctor before
ADALY 40MG INJECTION is administered to you if you are pregnant, think you may
be pregnant or breastfeeding.

The most common side effects of receiving ADALY 40MG INJECTION are pain,
redness, inflammation and swelling at the site of injection, nausea, vomiting,
headache, increased infections, skin rashes, tingling and numbness of skin,
brittle nails, hair loss, high blood sugar levels, shortness of breath and fast
heart rate. Consult your doctor if any of these side effect worsens.

Uses Of ADALY 40MG INJECTION

It is used to manage:

• severe joint pain and inflammation (rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis)
• back pain (Ankylosing spondylitis), neck pain and pain in bones of your head, back and chest (axial spondyloarthritis).
• plaque psoriasis (dry, itchy, scaly patches on the skin)
• hidradenitis suppurativa (painful skin condition causing abscess and scarring)
• inflammatory bowel disease (such as Crohn’s disease and Ulcerative colitis)
• eye inflammation (non-infective uveitis)

How ADALY 40MG INJECTION Works

ADALY 40MG INJECTION is a monoclonal antibody which acts by suppressing the
overactivity of your immune system. It reduces the activity of certain proteins
(TNF-alpha) in the body that causes abnormal immune responses, pain and
inflammation.

Therefore, it manages and manages joint pain and inflammation, back pain, neck
pain, inflammatory bowel diseases, skin conditions and eye conditions caused due
to abnormal immune response.

How to use ADALY 40MG INJECTION

ADALY 40MG INJECTION will be given to you by a doctor or a nurse beneath the
skin (subcutaneously). It can also be self-administered by the patient if
instructed by the doctor. Carefully follow the instructions advised by your
doctor in case of self-administration.

Your doctor will decide the correct dose and duration of therapy for you
depending upon your age, body weight and health condition.

Side Effects Of ADALY 40MG INJECTION

Common

• injection site reactions (including pain, swelling, redness or itching)
• increased infections (including skin infections, flu, gut infections, UTI, reproductive tract infections, oral infections, ear infections)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• nausea, vomiting
• headache, stomach pain, indigestion, bloating, heart burn, acid reflux
• skin rashes, bruising, skin inflammation, increased sweating
• musculoskeletal pain
• fungal infections, joint infections
• benign tumours, skin cancer
• allergic reactions (including skin itching, allergies, hay fever)
• dehydration, mood swings (including depression), anxiety
• difficulty in sleeping, migraine
• tingling or numbness of body parts
• vision disturbances, eye/eyelid inflammation or swelling
• vertigo (spinning sensation)
• fast heart rate, high blood pressure
• flushing, haematoma (collection of blood outside of blood vessels)
• asthma, shortness of breath
• sicca syndrome (including dry eyes and dry mouth)
• brittle nails, hair loss
• bloody urine
• chest pain, oedema (swelling), fever
• increased bleeding or bruising
• low RBC, WBC and platelet counts
• high blood lipid and uric acid levels
• low blood sodium, calcium, potassium, phosphorus levels in blood
• high blood sugar levels

Uncommon

• opportunistic infections (Ex. tuberculosis)
• neurological infections (Ex. viral meningitis)
• inflammation and infection of the large intestine
• cancers (lymph cancer, skin cancer)
• autoimmune conditions
• inflammation of blood vessels
• tremor, nerve pain
• stroke, problems in hearing
• shortness of breath or ankle swelling
• fluid collection in lungs, blood clot in lungs
• difficulty in swallowing
• gallbladder stones or inflammation
• night sweats, sleep disturbances
• impotence
• increased bilirubin levels

Rare

• multiple sclerosis
• nerve disorders, scarring of the lung
• hepatitis or relapse of hepatitis B infection

Contact your doctor immediately if you experience any of the following side
effects after receiving ADALY 40MG INJECTION:

• severe allergic reaction (such as skin rash, itching, swelling of the face, eyes, lips, tongue, throat, chest tightness, wheezing, dizziness)
• signs of infections (such as fever, wounds, feeling tired or dental problem)
• tuberculosis (cough that does not go away, weight loss, lack of energy, mild fever)
• severe infection in the blood (sepsis)
• signs of nerve damage (such as vision changes, weakness in your arms or legs or numbness or tingling in any part of your body)
• worsening symptoms of heart failure (such as shortness of breath or swelling of your feet)
• fever that does not go away, easy bruising or bleeding, pale skin
• changes in your skin, new lesion formation on the skin, skin discoloration or redness
• lupus-like syndrome (such as persistent unexplained rash, fever with joint pain and tiredness)
• shortness of breath, and swollen feet

How To Manage Side Effects

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

!### Injection Site Reactions

Place an ice pack on the injected site. Do not move the affected area
frequently. If the symptom worsens, consult your doctor.

Nausea And Vomiting

Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if
nausea worsens.

Warning & Precautions

!### Pregnancy

Monitoring requiredADALY 40MG INJECTION should be used in pregnant women only if considered
necessary by the physician. Therefore, inform your doctor before receiving it.
Women of childbearing age must use a suitable contrace
pregnancy while undergoing therapy with this medicine and until 5 months after
the last dose.

Mothers who received ADALY 40MG INJECTION during their pregnancy must inform
about this medicine to their baby’s doctor after the baby is born. This will
help your baby’s doctor to analyse your baby’s immune system and schedule
vaccination according to your baby health status.

!### Breastfeeding

Use with CautionADALY 40MG INJECTION should be used with caution in breastfeeding women.
Therefore, consult your doctor before receiving it.

!### Driving and Using Machines

Use with CautionADALY 40MG INJECTION may cause vision disturbances and spinning sensation.
Therefore, do not drive or operate any heavy tools or machines if your ability
is affected by this medicine.

!### Alcohol

Consult your doctorAvoid consum

!### Kidney

Use with CautionADALY 40MG INJECTION should be used with caution in patients with kidney
problems. Therefore, inform your doctor before receiving it.

!### Liver

Use with CautionADALY 40MG INJECTION should be used with caution in patients with active liver
infection (hepatitis B virus infection). Therefore, inform your doctor before
receiving it.

!### Allergy

ContraindicatedInform your doctor before receiving ADALY 40MG INJECTION if you are allergic to
Adalimumab.

!### Lungs

Consult your doctorADALY 40MG INJECTION is not recommended for use in patients with active
tuberculosis. It should be used with caution in patients with other lung
diseases (such as COPD). Therefore, inform your doctor before receiving it.

!### Heart Disease

Consult your doctorADALY 40MG INJECTION is not recommended for use in patients with moderate to
severe heart failure. It should be used with caution in patients who have a
previous history of serious heart condition. Therefore, inform your doctor
before receiving it.

!### Use In Pediatrics

Use with CautionADALY 40MG INJECTION should be used with caution in children and adolescents
(aged below 18 years). Proper dose adjustments and careful monitoring are
required in such patients.

!### Use In Geriatrics

Use with CautionADALY 40MG INJECTION should be used with caution in elderly patients. Therefore,
consult your doctor before receiving it. Proper dose adjustments and careful
monitoring are required in such patients.

Others

ADALY 40MG INJECTION is not recommended for use if you:

• have serious infections
• have symptoms of infections (such as fever, wounds, tiredness, dental problems)

Before receiving ADALY 40MG INJECTION, inform your doctor if you:

• are living in an infection prone zone
• live in an area where fungal infections are more common
• have recurrent infections or relapse of any previous infection
• have been in close contact with someone who have any serious infection (such as tuberculosis)
• have or develop a demyelinating disease (a disease that damages the myelin sheath (an insulating layer around the nerves), such as multiple sclerosis)
• recently received any vaccination
• have a habit of smoking

Interactions

A. Drug - Drug interactions:

Before receiving ADALY 40MG INJECTION, inform your doctor if you are taking any
of the following medicines:

• Other medicines used in the management of joint pain (such as azathioprine, anakinra and abatacept)
• 6-Mercaptopurine (a medicine used to manage cancer)

Overdosage:

ADALY 40MG INJECTION will be given to you only by a doctor or nurse in a
hospital, and so it is unlikely to receive an overdose. However, contact your
doctor immediately if you experience breathing difficulties, dizziness or
symptoms of low blood pressure or muscle stiffness.

Synopsis

Drug	:	Adalimumab
Pharmacological Category	:	TNF-alpha inhibitors
Therapeutic Indication	:	Pain relief
Dosage Forms	:	Injection, Prefilled Syringe

More Information

• Keep ADALY 40MG INJECTION out of reach of children
• Store ADALY 40MG INJECTION at room temperature

FAQs About ADALY 40MG INJECTION

Q: What isADALY 40MG INJECTIONused for?

A: ADALY 40MG INJECTION is used to manage severe joint pain and inflammation
(Ex. rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,
enthesitis-related arthritis, psoriatic arthritis). It can also be used to
manage other bone conditions such as ankylosing spondylitis (back pain) and
axial spondyloarthritis (pain in bones of your head, neck, back and chest).

It also helps in managing auto-immune conditions such as plaque psoriasis (dry,
itchy, scaly patches on the skin), hidradenitis suppurativa (painful skin
condition causing abscess and scarring), inflammatory bowel disease (such as
Crohn’s disease and Ulcerative colitis) and eye inflammation (non-infective
uveitis).

Q: What are the side effects of ADALY 40MG INJECTION?

A: The most common side effects of receiving ADALY 40MG INJECTION are pain,
redness, inflammation and swelling at the site of injection, nausea, vomiting,
headache, increased infections, skin rashes, tingling and numbness of skin,
brittle nails, hair loss, high blood sugar levels, shortness of breath and fast
heart rate. Consult your doctor if any of these side effect worsens.

Q: Can a person receiving ADALY 40MG INJECTION breastfeed?

A: ADALY 40MG INJECTION should be used with caution in breastfeeding women.
Therefore, consult your doctor before receiving it.

Q: Is ADALY 40MG INJECTION safe?

A: ADALY 40MG INJECTION is safe at doses prescribed by the physician.

Q: How ADALY 40MG INJECTION works?

A:ADALY 40MG INJECTION is a monoclonal antibody which acts by suppressing the
overactivity of your immune system. It reduces the activity of certain proteins
(TNF-alpha) in the body that causes abnormal immune responses, pain and
inflammation.

Q: Will ADALY 40MG INJECTION increases the risk of infection?A: Yes. ADALY 40MG INJECTION can increase the risk of infections. It
includes skin infections, flu, gut infections, UTI, reproductive tract
infections, respiratory tract infections, oral infections, ear infections,
fungal infections, meningitis, tuberculosis, or hepatitis. This is because ADALY
40MG INJECTION works by suppressing your immune system. Therefore, consult your
doctor immediately if you experience any signs of infection.

Q: Can I take other medicines for joint pain while receiving ADALY 40MG
INJECTION?A: ADALY 40MG INJECTION can be taken together with other joint pain
medications, steroids, and pain-relieving medicines (such as methotrexate,
sulfasalazine, hydroxychloroquine, leflunomide, injectable gold preparations,
prednisolone, indomethacin, etc.). However, consult your doctor before taking
them together.

Q: What type of drug is ADALY 40MG INJECTION?

A: ADALY 40MG INJECTION contains adalimumab which belongs to Disease modifying
antirheumatic drugs (DMARDs). It works by reducing the activity of certain
proteins (TNF-alpha) in the body that causes abnormal immune responses, pain and
inflammation.