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Get to know CONEXXENCE® (denosumab-bnht)
CONEXXENCE® (denosumab-bnht) is an FDA-approved biosimilar to Prolia® (denosumab) used for treatment:
of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Within healthy bones, old tissue is frequently broken down and replaced with new bone through osteoclasts and osteoblasts, respectively. The bone remodeling process allows bones to maintain their strength. However, for some, an imbalance of osteoclasts weakens their bones, leading to pain, fractures, and limited mobility.
CONEXXENCE blocks RANKL, a protein that tells bone cells to break down bone. By stopping RANKL, CONEXXENCE helps keep bones from breaking down too quickly, which protects them and makes them stronger with more mass.
CONEXXENCE must be given in the clinic by a healthcare provider as a subcutaneous (under-the-skin) injection in the upper arm, the upper thigh, or the abdomen.
Image is for illustrative purposes only.
Single-use pre-filled syringe
(60 mg)
You will receive your medicine by injection under the skin with a pre-filled syringe, which is a syringe that comes with medicine inside.
Get your injection every 6 months
You will get the injection in your healthcare provider's office once every 6 months.
Take calcium and Vitamin D every day
While you are on CONEXXENCE, you should take 1,000 mg of calcium and at least 400 IU of vitamin D each day to help keep your bones strong.
Mark Your Calendar
To stay on track and avoid missing your next dose, mark your calendar for the next scheduled injection date.
If you miss an injection, contact your healthcare provider's office as soon as possible to reschedule and receive the missed dose.
Talk to your healthcare provider if you or your caregiver have any questions about CONEXXENCE.
A biosimilar is a medicine that is highly similar to the original product (also called "reference product") with no clinically meaningful differences in safety, purity, or effectiveness.
CONEXXENCE® (denosumab-bnht) and Prolia® (denosumab) are similar in the following ways:
- Both made from living cells
- Work in the body in the same way
- Equally safe and effective
Why are biosimilars important?
- Help reduce costs for patients and healthcare systems
- Increase availability to more patients in need
- Encourage innovation in health care
"FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference [original] product."
—US Food and Drug Administration
- Filename
- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
- Size
- 1 MB
- Format
Resources for CONEXXENCE
Download CONEXXENCE resource materials
- Filename
- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
- Size
- 1 MB
- Format
Important Safety Information
What is the most important information you should know about Conexxence (denosumab-bnht)?
If you receive Conexxence, you should not receive other denosumab products at the same time.
Conexxence can cause serious side effects including:
Increased risk of severe low calcium levels in your blood (hypocalcemia). Conexxence may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Conexxence, it may get worse during treatment. Your low blood calcium must be treated before you receive Conexxence. Talk to your doctor before starting Conexxence. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Conexxence. Take calcium and vitamin D as your doctor tells you to.
If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Conexxence may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start Conexxence and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.
Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
- spasms, twitches, or cramps in your muscles
- numbness or tingling in your fingers, toes, or around your mouth
Serious allergic reactions have happened in people who take denosumab products. 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.
Severe jaw bone problems (osteonecrosis) may happen when you take Conexxence. Your doctor should examine your mouth before you start Conexxence, and may tell you to see your dentist before you start Conexxence. It is important for you to practice good mouth care during treatment with Conexxence.
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 Conexxence. Talk with your doctor before starting Conexxence treatment. After your treatment with Conexxence 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 Conexxence without first talking with your doctor. If your Conexxence 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 if you take Conexxence. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Conexxence. You may need to go to the hospital for treatment.
Conexxence is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system 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 may happen if you take Conexxence.
Bone, joint, or muscle pain. Some people who take denosumab products develop severe bone, joint, or muscle pain.
Do not take Conexxence if you: have low blood calcium level; are pregnant or plan to become pregnant, as Conexxence may harm your unborn baby; or are allergic to denosumab products or any of the ingredients in Conexxence.
Before taking Conexxence, tell your doctor about all of your medical conditions, including if you:
- Take other denosumab products.
- 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 Conexxence.
○ You should use an effective method of birth control (contraception) during treatment with Conexxence and for at least 5 months after your last dose of Conexxence.
○ Tell your doctor right away if you become pregnant while taking Conexxence. - Are breastfeeding or plan to breastfeed.
What are the possible side effects of Conexxence?
It is not known if the use of Conexxence over a long period of time may cause slow healing of broken bones. The most common side effects of Conexxence 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 Conexxence in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects Conexxence in patients with glucocorticoid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.
The most common side effects of Conexxence 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 denosumab-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of Conexxence. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Indications
Conexxence (denosumab-bnht) is indicated for treatment:
- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Please see Conexxence Full Prescribing Information and Medication Guide.
Indications
Conexxence (denosumab-bnht) is indicated for treatment:
- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer