ESENTRA 60mg Prefilled Syringe(Pfs) 1?s Allschoolabs -

Specification

INTRODUCTION
ESENTRA 60MG contains Denosumab which belongs to the group of medicines called Monoclonal antibody. It is used in the treatment of osteoporosis in women after menopause and in men who have an increased risk of fractures (broken bones) in order to reduce their risk of spinal, non-spinal and hip fractures. It is also used to treat bone loss (caused from a reduction in testosterone or long-term treatment with glucocorticoids). Osteoporosis is defined as a condition in which bones become weak and brittle. There are typically no symptoms in the early stages of osteoporosis, but once the bones have been weakened, there will be symptoms like back pain (caused by a fractured or collapsed vertebra), loss of height over time, stooped posture, and easy bone fractures.
Denosumab binds with high specificity and affinity to a protein (RANKL-mediator of bone resorption), inhibiting its action. As a result, osteoclast (cells which absorb and remove bone) formation, function and survival are inhibited helping in decreasing bone resorption. Along with this treatment, your doctor might ask you to make certain lifestyle changes such as maintaining good oral hygiene and quitting smoking.Your doctor may ask you to undergo a dental examination before you start the treatment.
ESENTRA 60MG is not recommended in patients having hypocalcemia (low calcium levels in blood). Before receiving ESENTRA 60MG, inform your doctor if you have any problems with your mouth or teeth (poor dental health, gum disease etc.). ESENTRA 60MG is not recommended among women who are pregnant. Consult your doctor for advice before receiving ESENTRA 60MG, If you are breast-feeding. ESENTRA 60MG is not recommended for children and adolescents (below 18 years). The most common side effects of receiving ESENTRA 60MG are pain in the bones, joints, muscles, arms and legs, painful urination, constipation, abdominal discomfort and skin rashes.
USES OF ESENTRA 60MG
Treats,
Osteoporosis and bone loss in women after menopause

Increased risk of bone fractures in men

Bone loss (caused from a reduction in testosterone or long-term treatment with glucocorticoids)

HOW ESENTRA 60MG WORKS
ESENTRA 60MG binds with high affinity to a protein (RANKL-mediator of bone resorption), inhibiting its action. As a result, osteoclast (cells which absorb and remove bone) formation, function and survival are prevented, helping in decreasing bone resorption.
DIRECTIONS FOR USE
ESENTRA 60MG will usually be administered subcutaneously (under the skin) by a doctor or nurse. You should also take calcium and vitamin D supplements while being on treatment with ESENTRA 60MG. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ESENTRA 60MG

COMMON

Pain in the bones, joints, muscles, arm or leg (pain in extremity) which is sometimes severe

Problems while urinating (painful, frequent, inability to hold urine, blood in urine)

Constipation

Abdominal discomfort

Skin conditions (rashes, itching, redness and/or dryness)

Hair loss (alopecia)

Upper respiratory tract infections

Pain, tingling or numbness that moves down the legs (sciatica)

UNCOMMON

Fever, vomiting and abdominal pain

Ear infections

Rash on the skin or sores in the mouth (lichenoid drug eruptions)
Stop taking ESENTRA 60MG and contact your doctor immediately if you experience any of the following side effects:
Skin infections (predominantly cellulitis), swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with fever

Spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness

Pain, swelling or non-healing of sores, discharge, numbness in the mouth or jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis)

New or unusual pain in your hip, groin, or thighs (indication of a possible fracture of the thigh bone)

Allergic reactions like swelling of the face, lips, tongue, throat, or other parts of the body; rashes, itching or hives on the skin, wheezing or difficulty in breathing

HOW TO MANAGE SIDE EFFECTS
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly.
Vomiting:
Stick to simple meals. Avoid eating oily and spicy foods.
Stomach pain:
Try to rest and relax. Have smaller and frequent meals. Keep a heating pad on your stomach. If the symptom does not improve, contact your doctor.
WARNING & PRECAUTIONS

PREGNANCY
ESENTRA 60MG is not recommended to receive if you are pregnant. If you become pregnant during treatment or less than 5 months after stopping treatment, then consult your doctor.
BREASTFEEDING
It is not known whether ESENTRA 60MG is excreted in human milk. Your doctor will help you decide whether to stop breast-feeding, or to stop the treatment, considering the benefits to the mother and the baby.
DRIVING AND USING MACHINES
ESENTRA 60MG has negligible influence on the ability to drive and use machines.
KIDNEY
?
ESENTRA 60MG should be received with caution in patients having severe kidney problems, kidney failure or have needed dialysis. Consult your doctor before receiving it.
ALLERGY
Inform your doctor before receiving ESENTRA 60MG if you are allergic to Denosumab.
OTHERS
ESENTRA 60MG is not recommended if you:
Have low levels of calcium in blood (hypocalcemia)
Before receiving ESENTRA 60MG, inform your doctor if you:
Have any problems with your mouth or teeth (poor dental health, gum disease)

Have not had a dental check-up recently.

Have a habit of smoking (increases dental problems)

Have cancer

Are under dental treatment or will undergo dental surgery in the near future (Ex. tooth extractions)
Use in pediatrics:
ESENTRA 60MG is not recommended for children and adolescents under 18 years of age. Consult your doctor before receiving it.
INTERACTIONS
A. Drug ? Drug interactions:
Before receiving ESENTRA 60MG, inform your doctor if you are taking any of the following medicine:
Glucocorticoids (such as prednisolone or dexamethasone)

Bisphosphonate (used to treat or prevent bone disorders)

Another medicine containing denosumab
Overdosage:
ESENTRA 60MG will be administered to you only by a doctor or a nurse. So, it is unlikely for you to receive an overdose. However, consult your doctor if you experience any unusual symptoms.
SYNOPSIS

Drug :?? Denosumab

Pharmacological Category :?? RANK ligand inhibitor

Therapeutic Indication :?? Osteoporosis

Dosage Forms :?? Injection

MORE INFORMATION

Keep ESENTRA 60MG out of reach of children.

Store in a refrigerator 2-8?C.

FAQs ABOUT ESENTRA 60MG
Can ESENTRA 60MG cause fatigue?
Yes, ESENTRA 60MG can cause fatigue (tiredness) which is one of the most common side effects. Consult your doctor for more information.
Is calcium needed along with ESENTRA 60MG?
Yes, one should also take calcium and vitamin D supplements while being on treatment with ESENTRA 60MG. Your doctor will discuss the right dosage with you.
Can I undergo dental procedures while receiving ESENTRA 60MG?
If you are under dental treatment or will undergo dental surgery (Ex. tooth extractions), inform your physician about it and tell your dentist that you are being treated with ESENTRA 60MG. If you wear dentures, you should make sure it fits properly. Contact your physician and dentist immediately if you experience any problems with your mouth or teeth (loose teeth, pain or swelling, or non-healing of sores or discharge)
Can ESENTRA 60MG cause bone fractures?
Yes, ESENTRA 60MG may rarely cause unusual fractures of the thigh bone. Contact your doctor if you experience unusual pain in your hip, groin or thighs as this may be an early indication of a possible fracture of the thigh bone.
REFERENCES
1. KD.Tripathi. Hormones and Drugs Affecting Calcium Balance. Essentials of Medical Pharmacology. Eight Edition. 2019. Page ? 371-372.
2. D A Hanley, J D Adachi, A Bell, V Brown.Denosumab: mechanism of action and clinical outcomes. [Revised on December 2012] [Accessed on 4th May 2022]?https://pubmed.ncbi.nlm.nih.gov/22967310/
3. Olivier Lamy, Delphine Stoll, B?reng?reAubry-Rozier, Elena Gonzalez Rodriguez.Stopping Denosumab. [Revised in February 2019] [Accessed on 4th May 2022]?https://pubmed.ncbi.nlm.nih.gov/30659428/
4. Amgen Technology (Ireland) Unlimited Company. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 4th May 2022]?https://www.medicines.org.uk/emc/files/pil.568.pdf
5. Denosumab. Mayoclinic. [Revised in August 2021] [Accessed on 4th May 2022]?https://www.mayoclinic.org/diseases-conditions/osteoporosis/symptoms-causes/syc-20351968
6. Denosumab. Chemocare. [Accessed in 4th May2022]?https://chemocare.com/chemotherapy/drug-info/denosumab.aspx
USEFUL DIAGNOSTIC TESTS

Bone density scan (X ray)

PRODUCT DETAILS

Net Qty

1 N

Item Weight

20 g

Ingredient

DENOSUMAB 60 MG

Hsn Code

30021500

Additional information

Weight
20 g