Details for: ZOLEDRONIC ACID INJECTION
Company: DR REDDY'S LABORATORIES LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02422433 | ZOLEDRONIC ACID INJECTION | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) | 5 MG / 100 ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Zoledronic acid injection is used:
- In the treatment of osteoporosis in postmenopausal women to reduce the risk of hip, vertebral, non-vertebral fractures (breaking bone) when given once a year.
- In the treatment to increase bone mineral density in men with osteoporosis when given once a year.
- In the treatment and prevention of osteoporosis, in men and women caused by glucocorticoid medicines such as prednisone, to increase bone mineral density, when given once a year.
- In the prevention of osteoporosis in postmenopausal women with low bone mass, given as a single treatment.
- In the treatment of Paget’s disease, given as a single treatment.
What it does
Zoledronic acid injection contains zoledronic acid which is a
member of a class of substances called Bisphosphonates.
Zoledronic acid injection binds specifically to bone and it does
not stay in your blood. Zoledronic acid injection slows down
bone resorption (caused by osteoclasts) which allows the bone-forming cells (osteoblasts) time to rebuild normal bone.
What is osteoporosis?
Osteoporosis is a disease that involves the thinning and
weakening of the bones, which is common in women after the
menopause and may also occur in men.
What is Paget’s disease of bone?
In Paget’s disease, bone breaks down too much and the new bone
made is not normal. If Paget’s disease is not treated, bones like
the skull, spine, and legs become deformed and weaker than
normal. This can cause problems like bone pain and arthritis. The
bones can also break easily. Paget’s disease of bone sometimes
runs in families. Paget’s disease may be discovered by X-ray
examination or blood tests.
When it should not be used
You should not be treated with Zoledronic acid injection if you:
- Have low calcium levels in your blood (Hypocalcemia) or vitamin D deficiency
- If you have severe kidney problems
- Are pregnant or plan to become pregnant.
- Are breast-feeding.
- Are allergic (hypersensitive) to zoledronic acid or any of the other ingredients of Zoledronic acid injection or any other bisphosphonate
What the medicinal ingredient is
zoledronic acid.
What the non-medicinal ingredients are
Mannitol, sodium citrate dihydrate, water for injection.
What dosage form it comes in
Zoledronic acid injection is a solution for intravenous infusion and comes in a 100 mL glass vial. Each 100 mL solution contains 5 mg of zoledronic acid.
Warnings and precautions
Be sure that you have discussed Zoledronic acid injection
treatment with your doctor.
If you are being treated with another intravenous form of
zoledronic acid, you should not be treated with Zoledronic
acid injection.
If you are being treated with Zoledronic acid injection, you
should not be treated with other bisphosphonates (such as
alendronate, risedronate, clodronate, etidronate, ibandronate
and pamidronate) at the same time.
Your doctor should inspect your mouth and may ask that you
have a dental examination prior to treatment with Zoledronic
acid injection. Dental work should be done before you
receive treatment with Zoledronic acid injection and dental
procedures should be avoided during treatment. It is
important that you practice good dental hygiene, routine
dental care and have regular dental check-ups while being
treated with Zoledronic acid injection. Immediately report
any oral symptoms such as loosening of a tooth, pain,
swelling, unhealed open wounds or sores, or discharge (pus
or oozing) during your treatment with Zoledronic acid
injection.
BEFORE you take Zoledronic acid injection talk to your doctor or pharmacist if you:
- Are of advanced age.
- Do not have enough water in your body (dehydration)
- Before or after you receive Zoledronic acid injection.
- Are unable to take daily calcium and/or vitamin D supplements
- Are breast-feeding.
- Have kidney problems. Worsening of kidney function, including kidney failure may happen when you take Zoledronic acid injection.
- Had some or all of your parathyroid glands or thyroid gland surgically removed
- Had sections of your intestine removed
- Need any dental procedures such as a root canal or tooth extraction (this does not include regular dental cleaning). Your doctor may possibly request a dental examination with any necessary preventive dentistry carried out prior to treatment with Zoledronic acid injection. You should continue regular dental cleanings and practice good oral hygiene.
- Have rapid and irregular heart beat
- Have a sudden headache, numbness in your face or limbs, particularly down one side of your body; experience confusion and have trouble talking or understanding what is being said to you; have vision problems, and trouble walking or keeping your balance.
- Have asthma from taking ASA (acetylsalicylic acid such as Aspirin®)
- Have any pain in your hip, groin, or thigh. Zoledronic acid injection cause unusual fractures in the thigh bone.
- Had or have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms
- Have sores in your mouth. This can lead to osteonecrosis of
the jaw. Your doctor may check if you:
- smoke
- have or have had tooth and/or gum disease
- have dentures that do not fit well
- have other medical conditions at the same time, such as: low red blood cell count (anemia) or if your blood cannot form clots in the normal way.
- Had or have joint stiffness, aches and pains and difficulty in movement (including of the hip, thigh, knee or upper arm) or pain in the ear, tell your doctor, as this may be a sign of bone damage due to loss of blood supply (osteonecrosis).
Zoledronic acid injection is not recommended for patients under
18 years of age.
Zoledronic acid injection is to be given by intravenous infusion in
no less than 15 minutes.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any you have bought without a prescription. It is especially important for your doctor to know if you are taking:
- any medicines known to be harmful to your kidneys (such as nonsteroidal anti-inflammatory drugs (NSAIDS)).
- Are pregnant or plan to become pregnant
- water pill (diuretics)
- aminoglycoside antibiotics (a type of medicine used to treat severe infections)
- calcitonin (a type of medicine used to treat high calcium levels in the blood)
- angiogenesis inhibitors (type of medicines used to treat cancer)
Can I continue my daily activities? After your Zoledronic acid injection infusion, there is no restriction on your normal activities such as standing, sitting, taking a walk or exercising.
Proper use of this medication
How is Zoledronic acid injection given?
Zoledronic acid injection is given as an infusion into a vein for
15 minutes by your doctor or nurse.
Your doctor will ask you to drink at least two glasses of water
(500 mL or 2 cups) before and after the treatment.
Usual dose:
For treatment of Osteoporosis: single dose of 5 mg once yearly
For prevention of Osteoporosis: single treatment of 5 mg.
For Paget’s disease: single treatment of 5 mg. Zoledronic acid
injection may work for longer than one year, and your doctor
will let you know if you need to be treated again.
The infusion nurse or doctor may ask you to stay for a short
period of time after the infusion.
It is very important to take calcium and vitamin D supplements
as directed by your doctor to reduce the possibility of having low
blood calcium levels, to prevent loss of bone and to help rebuild
bone.
Overdose
Side effects and what to do about them
Like all medicines, Zoledronic acid injection may have some
unwanted side effects in addition to its beneficial effects.
The most common side effects
Post-dose symptoms include:
- Fever
- Fatigue
- Chills
- Malaise (unwell feeling)
- Bone, joint and/or muscle pain or stiffness
- Headache
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Back pain
- Pain in extremity
- Influenza-like illness
- Weakness
- Pain
- Shortness of breath
- Dizziness
- Excessive sweating
- Tiredness
- Disturbed digestion
- Decreased appetite
- Non-cardiac chest pain
Other side effects:
- Low blood calcium (hypocalcaemia) the symptoms include numbness or tingling sensations (especially in the area around the mouth) or muscle spasms. Contact your doctor immediately if you notice any of these symptoms after your Zoledronic acid injection treatment.
- Allergic reactions such as itchy rash and swelling mainly of the face and throat.
- Increased or irregular heartbeat
- Rheumatoid arthritis/arthritis (inflammation of the joints)
- Urinary tract infection
- Constipation
- High blood cholesterol levels
- Pain in jaw
- Pain in neck
- Joint sprain
- Post-traumatic pain
- Cough
- Congestion of the nose
- Pharyngolaryngeal pain (pain at the back of the mouth and in the voice box)
- Seasonal allergy
- Vaginal dryness
- Sciatica (pain in the leg caused by injury to or compression of sciatic nerve)
- Hypoesthesia (reduced sense of touch)
- Rare cases of dehydration
- Persistent post-dose symptoms
- Jaw bone problems: rarely, patients have jaw problems associated with delayed healing and infection, often following tooth extraction.
- Very rare cases of low blood pressure
- Very rare cases of unusual fractures in a specific part of the thigh bone. If you develop new or unusual pain in the thigh or groin, contact your doctor.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | |
|---|---|---|---|
| Common | |||
| Post-dose symptoms: fever, chills, fatigue, pain, malaise | ✔ | ||
| Bone, joint, and/or muscle pain or stiffness | ✔ | ||
| Headache | ✔ | ||
| Nausea, vomiting, diarrhea, abdominal pain | ✔ | ||
| Shortness of breath | ✔ | ||
| Dizziness | ✔ | ||
| Excessive sweating | ✔ | ||
| Rash | ✔ | ||
| Uncommon | |||
| Tiredness, weakness, lethargy | ✔ | ||
| Hypocalcemia (low blood calcium): numbness, tingling sensation (especially in the area around the mouth), muscle spasms | ✔ | ||
| Rapid and irregular heartbeat, palpitations | ✔ | ||
| A sudden headache, numbness in your face or limbs, particularly down one side of your body; experience confusion and have trouble talking or understanding what is being said to you; have vision problems, and trouble walking or keeping your balance. | ✔ | ||
| Kidney failure: weakness, tiredness, loss of appetite, puffy eyes, hands and feet, changes in urine color or absence of urine production, changes in kidney function laboratory tests | ✔ | ||
| Eye disorder: Eye pain, light sensitivity, eye redness, decreased vision, eye inflammation | ✔ | ||
| Skin reactions: redness, swelling and/or pain at the infusion site | ✔ | ||
| Rare | |||
| Osteonecrosis of the jaw: numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in mouth, pain in the mouth, teeth or jaw, sores or non-healing sores in the mouth or discharge, dry mouth, swelling or gum infections, bad breath | ✔ | ||
| Very rare | |||
| Difficulty breathing with wheezing or coughing in asthma patients who are allergic to ASA | ✔ | ||
| Avascular necrosis (osteonecrosis) of the hip or knee or upper arm: poor blood supply to an area of bone leading to bone death: bone pain, joint pain, muscle spasms, joint stiffness | ✔ | ||
| Persistent ear pain | ✔ | ||
| Failure of broken bone to heal (nonunion) or broken bone taking longer than usual to heal (delayed union): persistent pain at the fracture site, no or slow progress in bone healing on imaging tests | ✔ | ||
| Severe allergic reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, loss of conscious due to shock (dangerously low blood pressure) | ✔ | ||
| Thigh or groin pain | ✔ | ||
| Unknown | |||
| Hypophosphatemia (low level of phosphate in blood): muscle weakness with trouble to swallow; you may be confused and irritable | ✔ | ||
If you have questions about these side effects, talk to your
doctor.
This is not a complete list of side effects. For any unexpected
effects while taking Zoledronic acid injection, contact your
doctor or pharmacist.
How to store
Store Zoledronic acid injection at room-temperature between
15°C-30°C. Keep the original packaging unchanged and sealed
until the doctor or the nurse administers Zoledronic acid
injection.
Remember to keep Zoledronic acid injection and all
medications out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Since it is not known how long Zoledronic acid injection should be continued for osteoporosis, you should discuss the need for retreatment with your doctor regularly to determine if Zoledronic acid injection is still right for you (note: Zoledronic acid injection is only approved to be used once for prevention of postmenopausal osteoporosis).
This document plus the full product monograph, prepared for
health professionals can be found by contacting the sponsor
Manufacturer:
Dr. Reddy’s Laboratories Limited
Bachupally 500 090 - INDIA
Imported/Distributed By:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga, ON L4W 4Y1 Canada
For more information contact:
1-855-845-1739 or druginfo@drreddys.com
Last Revised: August 1, 2019