Arylia (Denosumab) for Treatment of Osteoporosis and Bone Loss

Arylia contains the active ingredient Denosumab. Denosumab is a human monoclonal antibody that targets and binds with high affinity and specificity to RANKL. RANKL is a protein that is necessary for the function, formation, and survival of osteoclast. Arylia stops RANKL from activating its receptor RANK, present on the surface of osteoclasts. This prevents osteoclast function, formation, and survival, hence decreasing resorption of bone and increasing bone mass and strength.

It is used to treat:

• Osteoporosis in postmenopausal women and in men at increased risk of fractures.

• Bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and bone loss in females receiving aromatase inhibitor therapy for breast cancer.

• Bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

• If you have low calcium levels in your blood (hypocalcemia)

• If you ever had an allergic reaction to Denosumab or any of the ingredients present in this medicine

• Arylia is not recommended for children and adolescents under 18 years of age

• In pregnancy

• If you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned teeth extraction

• have or ever had kidney problems, kidney failure, have needed dialysis, or are taking medicines called glucocorticoids which may increase your risk of getting low blood calcium if you do not take calcium supplements

• Are a smoker

• Do not receive routine dental care or have not had a dental check-up for a long time

• Are taking medicines called corticosteroids

• Have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)

• Have cancer

• Are in concomitant therapies: chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck

• Have comorbid conditions (e.g. anemia, coagulopathies, infection)

• You always need to keep good oral hygiene while on Arylia and you may need to tell your dentist that you take Arylia. If you use dentures, then make sure they are well fitted. If you are under dental treatment or will undergo dental surgery, inform your doctor about your dental treatment and tell your dentist that you are being treated with Arylia

• Inform your doctor if you get pain, loose teeth, swelling, discharge, or sores in your mouth that do not heal, as these may be signs of ONJ

• Tell your doctor if you develop unusual pain in your thigh, hip, or groin. Some people have developed thigh bone fracture due to treatment with Arylia

• Tell your doctor if you have an allergy to latex

• If you are pregnant or planning to become pregnant. Arylia can harm your unborn baby. Make sure to use effective contraception while being treated with Arylia for at least 5 months after stopping treatment with Arylia

• If you are breastfeeding or planning to breastfeed. It is unknown if Arylia can pass into your breast milk

Arylia is available on prescription only and use Arylia exactly as prescribed by your doctor. You should also take calcium and vitamin D supplements while on treatment with Arylia.

The recommended dosage is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin.

Arylia is given as an injection under the skin (subcutaneous) and preferably in the other and upper areas of the arm, upper thigh surface (from 5 cm below the groin to 5 cm above the arm), or abdomen (5 cm from the navel).

• Skin infections: patients receiving Arylia may develop skin infections (Cellulitis)with symptoms of swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis: Stop using Arylia and tell your doctor or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • swelling of the face, mouth, and tongue
  • hives
  • itching
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • skin rash

• Osteonecrosis of the jaw: is a rare side effect that some patients get while being treated with Arylia. Inform your doctor if you get pain, loose teeth, swelling, discharge, numbness or heavy feeling in the mouth or sores in your mouth that do not heal, as these may be signs of ONJ.

• Hypocalcemia: You may have low levels of calcium in your body while receiving Arylia. You should tell your doctor if notice any of the following symptoms: spasms, twitches, or cramps in your muscle, and/or numbness or tingling in your fingers, toes, or around your mouth, and/or seizures, confusion, or loss of consciousness. Low calcium in the body may lead to changes in heart rhythm.

• Diverticulitis

• Musculoskeletal pain

• Lichen planus-like reactions (an inflammatory skin condition)

• Thigh fracture

• Allergic reactions that can damage the blood vessels mainly in the skin (hypersensitivity vasculitis)

• Osteonecrosis of the external auditory canal

• Bone, joint, and/or muscle which is sometimes severe

• Arm or leg pain

• Urinary infection with painful irritation, frequent urination, blood in the urine, inability to hold your urine

• Upper respiratory tract infection

• Sciatica

• Cataract

• Abdominal discomfort

• Constipation

• Rash, skin lesion

• Eczema

• Hair loss

• Ear infection

• Keep Arylia out of reach of children.

• Store in the refrigerator (2-8°C). Do not freeze.

• Do not shake.

• Keep Arylia in the original carton to protect it from light.

The active ingredient is Denosumab.

The inactive ingredients are sodium hydroxide, sorbitol (E420), acetic acid glacial, polysorbate 20, and water for injection.