DENOCLAST (r-DNA) injection is indicated
For treatment of women with osteoporosis after menopause at high risk for fracture
IMPORTANT
DENOCLAST is a biological product and requires storage between 2-8°C for efficacy. Online purchase from unauthorized agencies may not ensure proper refrigeration or cold chain maintenance.
Always insist on purchase from Zydus authorized/approved stockists only.
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain. From formulations to active pharmaceutical ingredients and animal healthcare products to wellness products, Zydus has earned a reputation amongst Indian pharmaceutical companies for providing comprehensive and complete healthcare solutions.
One of the salient features of Zydus is its rich history and lineage. The origin of the company dates all the way back to the 1950s. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
Zydus’ Innovation programme is spearheaded by 1400 researchers across 19 sites, working on differentiated medicines for the future. From NCEs to vaccines, biosimilars and niche technologies, the group is exploring different ideas and concepts, innovating constantly.
Adhering to its brand promise of being dedicated to life in all its dimensions, Zydus continues to innovate with an unswerving focus to address the unmet healthcare needs. Simultaneously it rededicates itself to its mission of creating healthier, happier communities across the globe.
For more information visit www.zyduslife.com
Important Safety Information
Do not take DENOCLAST if you:
have low blood calcium levels; or are pregnant or plan to become pregnant, as Denoclast may harm your unborn baby; or are allergic to Denoclast or any ingredients in Denoclast.
DENOCLAST can cause serious side effects:
Serious allergic reactions:
have happened in people who take DENOCLAST. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.
Low blood calcium (hypocalcemia):
DENOCLAST may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive DENOCLAST.
Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.
Severe jaw bone problems (osteonecrosis):
may occur. Your doctor should examine your mouth before you start DENOCLAST and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with DENOCLAST.
Unusual thigh bone fractures:
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying DENOCLAST:
Talk with your doctor before starting DENOCLAST treatment. After your treatment with DENOCLAST is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking DENOCLAST without first talking with your doctor. If your DENOCLAST treatment is stopped, talk to your doctor about other medicine that you can take.
Serious infections:
in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take DENOCLAST. You may need to go to the hospital for treatment.
DENOCLAST is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.
Skin problems:
such as inflammation of your skin (dermatitis), rash, and eczema have been reported.
Bone, joint, or muscle pain:
Some people who take DENOCLAST develop severe bone, joint, or muscle pain.
Before taking DENOCLAST, tell your doctor about all of your medical conditions, including if you:
- Have low blood calcium
- Cannot take daily calcium and vitamin D
- Had parathyroid or thyroid surgery (glands located in your neck)
- Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
- Have kidney problems or are on kidney dialysis
- Are taking medicine that can lower your blood calcium levels
- Plan to have dental surgery or teeth removed
-
Are pregnant or plan to become pregnant
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with DENOCLAST.
- You should use an effective method of birth control (contraception) during treatment with DENOCLAST and for at least 5 months after your last dose of DENOCLAST.
- Tell your doctor right away if you become pregnant while taking DENOCLAST.
- Are breast-feeding or plan to breast-feed
What are the possible side effects of DENOCLAST?:
It is not known if the use of DENOCLAST over a long period of time may cause slow healing of broken bones. The most common side effects of DENOCLAST in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of DENOCLAST in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of DENOCLAST in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.
The most common side effects of DENOCLAST in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in DENOCLAST -treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of DENOCLAST. Call your doctor for medical advice about side effects.
Indications
DENOCLAST is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
DENOCLAST is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.
DENOCLAST is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
DENOCLAST is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
DENOCLAST is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.
Please see DENOCLAST full Prescribing Information