Aukelso Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Aukelso Injection (denosumab-kyqq) is a RANKL inhibitor biologic medication that is a biosimilar to Xgeva (denosumab). It is given as an injection under the skin by a healthcare professional, typically once a month, to help prevent bone problems linked to certain cancers, treat giant cell tumor of bone, and manage high calcium levels caused by cancer. It works by blocking RANKL, a protein that signals the body to break down bone.

What is Aukelso Injection

Aukelso is a biologic medication that is a biosimilar to Xgeva (denosumab). It is given as an injection under the skin by a healthcare professional, typically once a month.

Aukelso Injection uses

• Prevention of bone problems in adults with multiple myeloma or certain cancers that have spread to the bones
• Giant cell tumor of bone in adults and certain teens who can't have surgery
• High calcium levels caused by cancer (hypercalcemia of malignancy) in adults after bisphosphonate treatment hasn't worked

Benefits of Aukelso Injection

• Helps reduce serious bone problems caused by cancers
• Can be used for many cancer-related bone conditions
• Typically injected once a month
• Helps reduce bone complications
• Helps lower the risk of pathologic fractures
• Helps control giant cell tumor of bone
• Helps lower excessively high blood calcium caused by cancer
• Targets RANKL, reducing osteoclast-mediated bone destruction

How Aukelso Injection works

Aukelso blocks a protein called RANKL that signals the body to break down bone. By blocking this protein, it slows bone loss, helps strengthen bones, and lowers the risk of bone problems caused by cancer.

Aukelso Injection dosage

Aukelso is given as an injection under the skin in the upper arm, upper thigh, or stomach by a healthcare professional. It is usually given once every 4 weeks, though additional doses may be given in the first month depending on the condition being treated. Blood tests are needed regularly to check calcium and other electrolyte levels during treatment. A healthcare provider may recommend calcium and vitamin D supplements, regular exercise, and a bone-healthy diet during treatment. Tell your dentist you are receiving this medicine before any dental procedure. Do not stop this medicine without first talking to your doctor, since stopping can raise the risk of bone problems. Do not use other medicines that contain denosumab while receiving this medicine.

Available forms and strengths

• Solution for injection (vial)
• Pre-filled syringe

Side effects of Aukelso Injection

Common

• Tiredness
• Low phosphate levels
• Nausea
• Diarrhea
• Low red blood cells
• Back pain
• Joint pain
• Pain in the arms and legs
• Headache
• Common cold symptoms
• Muscle or bone pain
• Toothache
• Vomiting
• Constipation
• Cough
• Shortness of breath
• Reduced appetite
• Swelling
• Rash

Serious

• Serious allergic reactions (dizziness, trouble breathing, tightness in throat, swelling in face and throat, itchiness, rash)
• Dangerously low calcium levels (tingling, numbness, muscle cramps, irregular heart rhythm, seizures, confusion)
• Osteonecrosis of the jaw (pain, swelling, exposed bone, bad breath, loose teeth, gum infection)
• Fractures (thigh pain, hip pain, groin pain)

Warnings and precautions

• Some people have had serious allergic reactions, including anaphylaxis, with symptoms such as trouble breathing, swelling of the face, lips, mouth, or throat, rash, itching, hives, or feeling faint. Get medical help right away if these occur.
• This medicine can cause low blood calcium levels, which can sometimes be serious. Risk is higher with severe kidney problems or not getting enough calcium and vitamin D.
• This medicine can rarely cause a serious jaw bone problem called osteonecrosis of the jaw, especially with longer treatment, dental procedures, poor mouth hygiene, or other risk factors.
• Unusual thigh bone fractures have occurred, sometimes without a fall or other injury, especially in people taking steroid medications.
• Stopping this medicine, especially after treatment for giant cell tumor of bone or in people whose bones are still growing, can cause dangerously high calcium levels, with the highest risk in the first year after the last dose.
• Stopping this medicine can raise the risk of fractures in the spine bones, especially in people with osteoporosis or a history of fractures. Do not stop without talking to your care team first.
• You should not receive this medicine if you have untreated low calcium levels in your blood; this must be treated first.
• This medicine can cause serious harm to an unborn baby, so it is not safe during pregnancy. You may need a pregnancy test before starting treatment. Use effective birth control during treatment and for at least 5 months after your last dose. Tell your prescriber right away if you become pregnant.
• Talk with your care team before breastfeeding while taking this medicine. Small amounts might pass into breast milk, but it's not known how it might affect a breastfed child.
• People with serious kidney problems have a higher risk of low calcium levels while on this medicine.
• No standard liver-specific dosage adjustment is established.
• No major direct interaction with alcohol is established, but alcohol use should be discussed with the treating oncology team.
• This medicine usually does not directly impair driving; avoid driving if weakness or dizziness occurs.

Storage

• If you keep this medicine at home, store it in the original carton in a refrigerator
• Protect from light and do not freeze
• Do not shake the medicine
• After taking it out of the refrigerator, you may keep it at room temperature for up to 14 to 63 days, depending on the brand form
• Store in the original container away from heat and light

When to see a doctor

• Get emergency medical help if you have signs of an allergic reaction such as hives, difficult breathing, or swelling of your face, lips, tongue, or throat.
• Call your doctor right away if you have new or unusual pain in your thigh, hip, or groin; jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work; or signs of low blood calcium such as muscle spasms, numbness, or tingling around your mouth or in your fingers and toes.
• After stopping this medicine, tell your doctor if you have symptoms of high calcium levels such as confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, or weight loss.

Alternatives

• Denosumab (Xgeva)
• Zoledronic acid
• Pamidronate