Aclasta Drug Presentation
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Transcript of Aclasta Drug Presentation
DRUG PRESENTATION:
ZOLEDRONIC ACID (ACLASTA)
Presented by: CZARINA MAE F. CID
Zoledronic Acid (ACLASTA)
CLASS Biphosphonates
First and only once-yearly medicine for osteoporosis
MECHANISM OF ACTION Aclasta slows down bone resorption,
allowing the bone-forming cells time to rebuild normal bone.
DOSING
In ready to use plastic bottles 5 mg doses in 100 mL aqueous solution Single dose should not exceed 5 mg Given once a year.
BONE
STRUCTURE Compact (cortical) bone
The hard outer layer of bones is composed of compact bone tissue, so-called due to its minimal gaps and spaces. This tissue gives bones their smooth, white, and solid appearance, and accounts for 80% of the total bone mass of an adult skeleton.
Trabecular (cancellous) bone Filling the interior of the bone is the trabecular
bone tissue (an open cell porous network also called cancellous or spongy bone), which is composed of a network of rod- and plate-like elements that make the overall organ lighter and allow room for blood vessels and marrow.
BONE
CELLULAR STRUCTURE Osteoblasts are mononucleate bone-forming
cells which mineralizes to become bone. Osteocytes originate from osteoblasts that
have migrated into and become trapped and surrounded by bone matrix that they themselves produce. They are mature bone cells.
Osteoclasts are the cells responsible for bone resorption, thus they break down bone.
INDICATIONS & DOSING
INDICATION DOSING
Prevention of postmenopausal osteoporosis in women
5 mg IV infusion every 2 years
Treatment of osteoporosis in men 5 mg IV per year
Treatment of Paget’s disease of bone
5 mg given as one-time IV infusion; rarely needs re-treatment within 5 years
Treatment of glucocorticoid-induced osteoporosis
5 mg IV per year
Prevention of clinical fractures in patients after hip fracture
5 mg IV per year
Prevention of glucocorticoid-induced osteoporosis
5 mg IV per year
Treatment of postmenopausal osteoporosis in women
5 mg IV per year
OSTEOPOROSIS
A disease where the bone mineral density (BMD) is reduced, bone microarchitecture deteriorates, and the amount and variety of proteins in bone is altered which leads to an increased risk of fracture
Osteoporotic fractures are those that occur in situations where healthy people would not normally break a bone; aka. fragility fractures - vertebral column, rib, hip and wrist
OSTEOPOROSIS
POST MENOPAUSAL OSTEOPOROSIS Results from a lack of estrogen (e.g. as a
result of menopause) which increases bone resorption as well as decreases the deposition of new bone that normally takes place in weight-bearing bones.
OSTEOPOROSIS
Glucocortocoid-induced osteoporosis (GIOP)
PAGET’S DISEASE
Aka osteitis deformans or osteodystrophia deformans
Chronic disorder that can result in enlarged and misshapen bones. The excessive breakdown and formation of bone tissue causes affected bone to weaken, resulting in pain, misshapen bones, fractures, and arthritis in the joints near the affected bones.
Typically is localized Of viral or genetic etiology No cure
CONTRAINDICATION
Aspirin-sensitive asthma Dental disease Kidney disease Hypocalcemia Allergic sensitivity to similar medicine Pregnant or trying to get pregnant Breast feeding Patients already receiving Zometa Malabsorption syndrome Bone cancer
DRUG INTERACTIONS
Medicines that can harm your kidneys Diuretics – bumetanide and furosemide Certain antibiotics given by injection NSAIDs, medicines for pain and inflammation
– ibuprofen, naproxen Cancer medicine* Tell health care provider all medicines, herbs,
non-prescription drugs and dietary supplements,
* Smoking, drinking or illegal drugs
SIDE EFFECTS
Needs immediate intervention (Emergency): Allergic reactions: skin rash, itching or hives,
swelling of the face, lips or tongue, breathing problems
Serious side-effects: Urinating less than usual or not at all Muscle spasms, numb or tingly feeling (especially
around your mouth) Severe joint, bone, or muscle pain Jaw burning, cramping or pain – OSTEONECROSIS Fainting
HYPOCALCEMIA
Less than 2.1 mmol/L or 9 mg/dl or an ionized calcium level of less than 1.1 mmol/L or 4.5 mg/Dl Normal serum calcium: 2.2-2.6 mmol/L (9-
10.5 mg/dL) Normal ionized calcium:1.1-1.4 mmol/L
(4.5-5.6 mg/dL)
HYPOCALCEMIA
"CATS go numb” Petechiae Oral, perioral and acral paresthesias, tingling or 'pins and needles'
sensation in and around the mouth and lips, and in the extremities of the hands and feet
Carpopedal and generalized tetany Latent tetany
Trousseau sign of latent tetany Chvostek's sign
Tendon reflexes are hyperactive Life threatening complications
Laryngospasm Cardiac arrhythmias
ECG changes include: Intermittent QT prolongation; puts the patient at high risk of torsades de
pointes
OSTEONECROSIS OF THE JAW (ONJ)
severe bone disease that affects the maxilla and the mandible.
Signs / symptoms: The definitive symptom of ONJ is the exposure of mandibular or maxillary bone through lesions in the gingiva that do not heal. Pain inflammation of the surrounding soft tissue secondary infection or drainage may or
may not be present.
SIDE EFFECTS
Do not usually require medical attention (report if it continues): Bone, joint or muscle pain Fever Irritation at IV site Loss of appetite Nausea and vomiting Stomach upset Feeling of fatigue
OVERDOSE
Signs and Symptoms Numbness or tingling in your hands and
feet Muscle stiffness Spasms in the muscles of your face Uneven heartbeats Wheezing or trouble breathing.
PRE-INFUSION CONSIDERATIONS Dental exam for preventive tooth and gum care Correct disturbances of mineral metabolism - Calcium and
vitamin D Ensure calcium is in normal range: 2.0-2.6mmol/L Vitamin D supplementation:
If patient is not on Vitamin D, administer 2 x 1.25mg calciferol during the week before infusion
Instruct patients to continue taking Vitamin D supplements (calciferol 1.25mg per month)
Confirm creatinine clearance is ≥35 mL/min. Do not infuse Aclasta in patients with creatinine clearance of <35 mL/min
On the day of the infusion, it is important to drink at least 500 mL (2 cups) of fluids before and after the treatment.
DURING THE INFUSION
Infuse over no less than 15 minutes over a constant infusion rate
Infuse at a slower rate in elderly patients Flushing is recommended Must be given in a separate, vented IV
line. Do not mix with other medication and must not come in contact with any calcium- or divalent cation-containing solution
POST INFUSION
In patients at risk for renal failure, consider interim monitoring of renal function
All patients should be instructed on the importance of calcium and vitamin D supplementation. Paget's disease: patient should also receive 1500 mg of elemental calcium and
800 IU vitamin D daily, especially during the 2 weeks after the injection of zoledronic acid.
It is strongly advised that patients with Paget’s disease receive adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice a day and vitamin D, this should be ensured during the initial 10 days following Aclasta administrationn
Transient postdose symptoms (fever, myalgia, flu-like symptoms, headache and arthralgia) occur within 3 days of infusion and most resolved within 3 days of onset - Paracetamol or ibuprofen given up to 3 days after Aclasta
Adequate calcium and vitamin D intake prior to Aclasta therapy in patients with preexisting hypocalcaemia, and for 10 days following Aclasta in patients with Paget's disease of the bone
STORAGE AND STABILITY
Keep unopened vial below 30˚C. Opened vials should be used
immediately. Unused, opened vials can be stored up
to 24hrs at 2-8 ˚ C Discard any unused contents of the vial
after infusion. Alcasta must reach room temperature
prior to infusion if refrigerated.
THANK YOU!