Aukelso
Aukelso (denosumab or denosumab-kyqq) is a biologic medication that's a biosimilar to Xgeva (denosumab). It's a RANKL inhibitor used to help prevent serious bone problems caused by cancer, treat giant cell tumor of bone, and lower high calcium levels in people who have cancer. A healthcare professional gives the medication as an injection under the skin, typically once a month. Common side effects include nausea, tiredness, and diarrhea.
What is Aukelso (denosumab)?
What is Aukelso (denosumab) used for?
- 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
How Aukelso (denosumab) works
Aukelso (denosumab) is a RANKL inhibitor. It works by blocking RANKL, a protein that signals your body to break bone down.
By blocking this protein, Aukelso (denosumab) slows bone loss, helps strengthen your bones, and lowers the risk of bone problems caused by cancer.
Drug facts
| Common Brands | Aukelso |
|---|---|
| Drug Class | RANKL inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Aukelso (denosumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Cancer that has spread to the bones:
- Tiredness (45%)
- Low phosphate levels (32%)
- Nausea (31%)
Multiple myeloma:
- Diarrhea (34%)
- Nausea (32%)
- Low red blood cells (22%)
- Back pain (21%)
Giant cell tumor of bone: (all ≥ 10%)
- Joint pain
- Back pain
- Pain in the arms and legs
- Tiredness
- Headache
- Nausea
- Common cold symptoms
- Muscle or bone pain
- Toothache
- Vomiting
- Low phosphate levels
- Constipation
- Diarrhea
- Cough
High calcium due to cancer:
- Nausea (30%)
- Shortness of breath (27%)
- Reduced appetite (24%)
- Headache (24%)
- Swelling (24%)
- Vomiting (24%)
- Low red blood cell count (21%)
- Constipation (21%)
- Diarrhea (21%)
Less Common Side Effects
Cancer that has spread to the bones:
- Shortness of breath
- Diarrhea
- Low calcium levels
- Cough
- Headache
Multiple myeloma:
- Low platelet levels
- Swelling
- Low calcium levels
- Upper respiratory tract infection
- Rash
- Headache
Giant cell tumor of bone:
- Jaw problems
- Low red blood cell count
- Pneumonia
- Back pain
High calcium due to cancer:
- Tiredness
- Infection
Aukelso (denosumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reactions: dizziness, trouble breathing, tightness in your throat, swelling in your 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
The following Aukelso (denosumab) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
cracked, dry, or scaly skin
difficult, burning, or painful urination
frequent urge to urinate
muscle or bone pain
pain in the arms or legs
rash
skin rash, encrusted, scaly, and oozing
swelling
Less common
Arm or jaw pain
bloating or swelling of the face, arms, hands, lower legs, or feet
body aches or pain
chest pain or discomfort
chest tightness or heaviness
chills
confusion
congestion
difficulty with breathing
difficulty with moving
dryness or soreness of the throat
ear congestion
fast or irregular heartbeat
headache
hoarseness
joint pain
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle stiffness
numbness and tingling around the mouth, fingertips, hands, or feet
pain in the lower back, bottom, upper leg, or hips
painful blisters on the trunk of the body
pale skin
rapid weight gain
runny or stuffy nose
seizures
stomach cramps
swollen joints
tender, swollen glands in the neck
trouble swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
voice changes
Rare
Blood in the stool
change in bowel habits
clear or bloody discharge from the nipple
darkened urine
difficulty with eating
dimpling of the breast skin
indigestion
inverted nipple
itching, pain, redness, swelling, tenderness, or warmth on the skin
loss of appetite
lower back or side pain
lump in the breast or under the arm
lump or swelling in the abdomen or stomach
pains in the stomach, side, or abdomen, possibly radiating to the back
persistent crusting or scaling of the nipple
raised, firm, and bright red patches of the skin on the arm or leg
redness or swelling of the breast
sore on the skin of the breast that does not heal
stomach discomfort
unexplained weight loss
vomiting
yellow eyes or skin
Incidence not known
Heavy feeling in the jaw
loose teeth
pain, swelling, or numbness in the mouth or jaw
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Dizziness or lightheadedness
excess air or gas in the stomach or bowels
feeling of constant movement of self or surroundings
feeling of fullness
lack or loss of strength
passing gas
redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
sensation of spinning
trouble sleeping
upper abdominal or stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Aukelso (denosumab)
Pros
- Helps reduce serious bone problems caused by cancers
- Can be used for many cancer-related bone conditions
- Typically injected once a month
Cons
- Must be injected by a healthcare professional
- Requires regular blood tests
- Not safe in pregnancy
Pharmacist tips for Aukelso (denosumab)
- Aukelso (denosumab) is given as an injection under the skin by a healthcare professional, usually once every month. The injection is given in your upper arm, upper thigh, or stomach.
- Keep all of your Aukelso (denosumab) appointments. You might also need regular blood tests to check your calcium and other electrolyte levels during treatment.
- Your prescriber might recommend calcium and vitamin D supplements, regular exercise, and a bone-healthy diet while receiving Aukelso (denosumab). Follow their recommendations to help keep your bones strong.
- Aukelso (denosumab) can cause low calcium levels in the blood. Tell your prescriber right away if you develop muscle cramps, tingling around your mouth, or numbness in your fingers or toes.
- Tell your dentist that you're receiving Aukelso (denosumab) before any dental procedure. This medication can rarely cause a serious jaw problem called osteonecrosis of the jaw.
- Tell your care team if you develop new or unusual pain in your thigh, hip, or groin while taking Aukelso (denosumab). This can be an early sign of a rare thigh bone fracture.
- Tell your prescriber if you're taking other denosumab products before starting Aukelso (denosumab) since they shouldn't be used together.
- Aukelso (denosumab) can interact with some medications and supplements. Share a complete list of everything you take with your care team before starting treatment.
- Pregnancy: Tell your prescriber right away if you become pregnant while taking Aukelso (denosumab). If you can become pregnant, use effective birth control during treatment and for 5 months after your last dose.
- Breastfeeding: Talk with your care team before breastfeeding while taking Aukelso (denosumab). Small amounts of the medication might pass into breast milk, but it's not known how it might affect a breastfed child.
Risks and warnings for Aukelso (denosumab)
Aukelso (denosumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reactions
Some people who received Aukelso (denosumab) have reported serious allergic reactions, including anaphylaxis. Symptoms can include trouble breathing, swelling of your face, lips, mouth, or throat, rash, itching, hives, or feeling faint. Get medical help right away if you experience these symptoms.
Low calcium levels
- Risk factors: Serious kidney problems | Not taking calcium supplements | Taking other medications that can lower calcium blood levels
Aukelso (denosumab) can cause low blood calcium levels in your blood, which can sometimes be serious. Your risk is higher if you have severe kidney problems or don't get enough calcium and vitamin D.
Your care team will check your calcium levels before and during treatment. They might recommend calcium and vitamin D supplements while you're receiving Aukelso (denosumab). Tell your prescriber right away if you have muscle cramps, tingling around your mouth, or numbness in your fingers or toes, since these can be signs of low calcium.
Jaw bone problems (osteonecrosis of the jaw)
- Risk factors: Dental procedures during treatment | Receiving Aukelso (denosumab) long term | Wear dentures | Taking medications that weaken the immune system, certain medications that stop tumors from growing, or steroids | Poor mouth hygiene | History of gum infections | Diabetes
Although rare, Aukelso (denosumab) can cause osteonecrosis of the jaw (ONJ), a condition where part of the jaw bone breaks down. Symptoms can include jaw pain, swelling, tooth or gum infections, loose teeth, or slow healing after a dental procedure. Your risk might be higher the longer you receive treatment.
To help lower your risk, practice good mouth hygiene and have regular dental checkups. Your prescriber might recommend a dental exam before you start treatment. Tell your dentist that you're taking Aukelso (denosumab), and let your prescriber know before having any dental procedures. Contact your care team right away if you develop jaw pain, swelling, or sores in your mouth that don't heal.
Thigh bone fractures
- Risk factors: Taking steroid medications
Although rare, people taking Aukelso (denosumab) have experienced unusual thigh bone fractures, sometimes without a fall or other injury. Tell your prescriber right away if you have new or unusual pain in your hip, thigh, or groin. This pain can be an early warning sign of a fracture, and your care team might want to check your bones.
High calcium levels after stopping treatment
- Risk factors: Giant cell tumor of bone | Being at an age where your bones are still growing
Aukelso (denosumab) can cause dangerously high calcium levels after you stop treatment, especially if you're taking it for a giant cell tumor of bone or if your bones are still growing. This risk is highest during the first year after your last dose.
Tell your prescriber right away if you have loss of appetite, stomach pain, nausea, vomiting, constipation, increased thirst, frequent urination, or unusual tiredness.
Spinal fractures after stopping treatment
- Risk factors: History of fractures | History of osteoporosis
Stopping Aukelso (denosumab) can raise your risk of fractures in the bones of your spine, especially if you have osteoporosis or have had fractures in the past. Don't stop the medication without talking to your care team first. Tell your prescriber right away if you develop new or worsening back pain if you do stop treatment.
Harm to unborn baby
Aukelso (denosumab) can cause serious harm to an unborn baby, so it's not safe in pregnancy. Before you start treatment, your healthcare team might ask you to take a pregnancy test to make sure you're not pregnant.
If you can become pregnant, use effective birth control while receiving Aukelso (denosumab) and for at least 5 months after your last dose. Tell your prescriber right away if you become pregnant during treatment.
Aukelso (denosumab) dosage
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.7ml of 120mg/1.7ml | 1 vial | $2,886.25 | $2,886.25 |
Typical dosage for Aukelso (denosumab)
Aukelso (denosumab) is given as an injection under the skin in the upper arm, upper thigh, or stomach by a healthcare professional.
-
Prevention of bone problems in people with cancer: The typical dose is 120 mg injected under the skin every 4 weeks.
-
Giant cell tumor of bone and high calcium levels caused by cancer: The typical dose is 120 mg injected under the skin every 4 weeks. In the first month of treatment, you'll receive an additional 120 mg on Day 8 and 15.
Interactions between Aukelso (denosumab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
How much does Aukelso (denosumab) cost?
$2,886.25
Aukelso (denosumab) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Aukelso (denosumab) will not be safe for you to take.
- Low calcium levels that are untreated
What are alternatives to Aukelso (denosumab)?
Aukelso (denosumab) images
