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Zometa medicine 4mg / 5ml Zoledronic Acid for treatment of bone marrow cancer
- Brand name: Zometa 4mg / 5ml
- Active ingredient: Zoledronic Acid
- Manufacturer: NOVARTIS
- Content: A vial with a concentrated 5ml contains 4mg of zoledronic acid, which corresponds to 4,264mg of zoledronic monohydrate acid.
- Form: infusion every 1 ml of crystal contains 0.8 mg of zoledronic acid.
- Package: 5ml bottle containing 4mg of zoledronic acid
- Zometa Drug Prices: COMMENT below for prices OR Click on the link: https://thuoclp.com/chatFB type “Zometa”
What is Zometa?
Zometa (zoledronic acid) belongs to a class of drugs called bisphosphonates (bisfosfat). zoledronic acid inhibits the release of calcium from bones.
Zometa is used to treat high blood calcium levels caused by cancer (hypercalcemia of malignancy). Zometa also treats bone marrow pain (a type of bone marrow cancer) or bone cancer that has spread to other parts of the body.
The brand Reclast acid zoledronic is used to treat Paget’s disease, and to treat or prevent osteoporosis in postmenopausal women or those taking certain steroid medications. Reclast is also used to increase bone mass in men with osteoporosis.
You should not be treated with Reclast if you have received Zometa.
Zometa may also be used for purposes not listed in this medication guide.
Indications for treatment
- Prevention of bone-related problems (pathological fractures, spinal compression, radiation or surgery to bone, or tumor-induced hypercalcemia) in adult patients with advanced malignancies bone related.
- Treatment of adult patients with tumor-induced hypercalcemia (TIH).
Dosage and method of administration of Zometa
Zometa must only be prescribed and administered to the patient by healthcare professionals experienced in administering intravenous bisphosphonates. Patients treated with Zometa should be provided with package leaflets and patient reminder cards.
Amount
Prevention of bone-related events in patients with advanced bone-related malignancies
Adults and old people
The recommended dose in preventing bone-related events in patients with advanced bone-related malignancies is 4 mg of zoledronic acid every 3 to 4 weeks.
Patients should also be administered a 500 mg oral calcium supplement and 400 IU of vitamin D daily.
The decision to treat patients with bone metastases for the prevention of related bone events should consider that the start of treatment effect is 2-3 months.
Handling TIH
Adults and old people
The recommended dose in hypercalcemia (albumin-serum calcium ≥ 12.0 mg / dl or 3.0 mmol / l) is a single dose of 4 mg zoledronic acid.
CKD
Treatment in Zometa TIH patients with severe renal impairment should be considered after assessing the risks and benefits of treatment. In clinical studies, patients with serum creatinine> 400 mmol / l or> 4.5 mg / dl were excluded. No dose adjustment is needed in patients with serum creatinine <400 mmol / l or <4.5 mg / dl TIH (see section 4.4).
Prevention of bone-related events in patients with advanced bone-related malignancies:
At the beginning of treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumors, serum creatinine and creatinine clearance (CLcr) should be determined. CLcr is calculated from serum creatinine using the Cockcroft-Gault formula. Zometa is not recommended for patients with severe renal impairment before treatment initiation, defined for this patient as CLcr <30 ml / min. In clinical trials with Zometa, patients with serum creatinine> 265 mmol / l or> 3.0 mg / dl were excluded.
In patients with bone metastases who exhibit mild to moderate kidney damage before starting treatment, defined for this subject as CLcr 30-60 ml / min, the following Zometa doses are recommended:
| Baseline creatinine clearance (ml / min) | Zometa recommended dose * |
| > 60 | 4.0 mg of zoledronic acid |
| 50-60 | 3,5 mg * zoledronic acid |
| 40-49 | 3,3 mg * zoledronic acid |
| 30-39 | 3,0 mg * zoledronic acid |
* The calculated dose assumes an AUC target of 0.66 (mg • hr / l) (CLcr = 75 ml / min). Dose reductions for patients with renal insufficiency are expected to achieve the same AUC as seen in patients with creatinine clearance of 75 ml / min.
After starting treatment, serum creatinine should be measured before each dose of Zometa and treatment should be withheld if renal function has been impaired. In clinical trials, impaired kidney is defined as follows:
- For patients with normal serum creatinine (<1.4 mg / dl or <124 mmol / l), an increase of 0.5 mg / dl or 44 mmol / l;
- For patients with abnormally basic creatinine (> 1.4 mg / dl or> 124 mmol / l), an increase of 1.0 mg / dl or 88 mmol / l.
In clinical studies, Zometa treatment was only resumed when creatinine levels returned within 10% of the original value. Zometa treatment should be resumed at the same dose given before treatment is interrupted.
For children
The safety and effectiveness of zoledronic acid in children aged 1 year to 17 years have not been determined. Currently available data are described in sections and 5.1 but no recommendations on a Dose can be made.
Managing method
Use intravenously.
Zometa 4 mg concentrated for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion for no less than 15 minutes.
In patients with mild to moderate renal impairment, a Zometa dose reduction is recommended (see “Doses” above and section 4.4).
Instructions for dose reduction Zometa
Withdraw the appropriate amount of the required focus, as follows:
- – 4.4 ml for 3.5 mg dose
- – 4.1 ml at a dose of 3.3 mg
- – 3.8 ml at a dose of 3.0 mg
For instructions on dilution of a medicinal product before use, see section 6.6. The withdrawn concentration should be further diluted in 100 ml of aqueous solutions of 0.9% w / v sodium chloride solution or 5% w / v glucose solution. The dose should be considered as a single intravenous infusion for not less than 15 minutes.
Concentrated Zometa should not be mixed with calcium or other bivalent-containing cation solutions such as Ringer lactate solution, and should be used as a single intravenous solution in a separate infusion line.
Patients should be well maintained hydrated before and after taking Zometa.
How to use the medicine ?
Zometa is injected into a vein through an IV. A health care provider will give you this injection.
Drink at least 2 glasses of water within a few hours before your injection to avoid dehydration.
Your doctor may want you to take a calcium and / or vitamin D supplement while you are being treated with Zometa. Carefully follow your doctor’s instructions about the type and power of calcium to take.
You may need frequent medical exams to help your doctor determine how long to treat you with Zometa. Your kidney function may also need to be checked.
What should i avoid while passing zometa?
Avoid any kind of dental surgery while you are being treated with Zometa. It may take longer than usual for you to recover.
Important information Zometa drugs
Do not use Zometa if you are pregnant. It can harm an unborn baby.
Follow all directions on the medicine and package labels. Tell each of your health care providers about all your medical conditions, allergies, and all medications you use.
Your doctor may recommend having a dental exam for preventative teeth and gum care before starting your treatment with Zometa. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor oral health.
Some people using drugs similar to Zometa have developed jaw bone loss, also known as jaw bone necrosis. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or delayed post-traumatic injury or gum surgery. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include clotting disorders, anemia (low red blood cells), and preexisting dental problems.
Avoid any kind of dental surgery while you are being treated with Zometa. It may take longer than usual for you to recover.
Zometa may harm your kidneys. This effect is increased when you also use other medicines that are harmful to the kidneys, such as: chemotherapy, antiviral drugs, pain or arthritis medications, antibiotics, or medications to treat the disorder. intestinal disorders or preventing organ transplant rejection.
Note before using the drug Zometa
You should not use Zometa if you are allergic to zoledronic acid.
You also should not use Reclast if you have:
- Severe kidney disease; or
- Low levels of calcium in your blood.
To make sure Zometa is safe for you, tell your doctor if you have:
- kidney disease;
- a history of thyroid or parathyroid surgery;
- malabsorption syndrome (inability to properly absorb food and nutrients);
- a history of surgical removal of a part of your gut;
- asthma caused by aspirin;
- dental work plan or oral surgery;
- if you are dehydrated;
- if you take a diuretic (“liquid medicine”); or
- If you are using other bisphosphonates (alendronate, etidronate, ibandronate, pamidronate, risedronate, Actonel, Fosamax, Boniva, and others).
In rare cases, Zometa can cause bone loss (necrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or delayed healing after dental work. The longer you use Zometa, the more likely you are to develop this condition.
Osteonecrosis of the jaw can be more likely if you have cancer or receive chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Your doctor may recommend having a dental exam for preventative teeth and gum care before starting your treatment with Zometa. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor oral health.
FDA pregnancy category D. Do not use Zometa if you are pregnant. It can harm an unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Zoledronic acid can pass into breast milk and may harm a nursing baby. You should not breastfeed while using this medication.
Zometa side effects
Get emergency medical help if you have any signs of an allergic reaction to Zometa : hives; wheezing, chest tightness, shortness of breath; swelling of face, lips, tongue, or throat.
Call your doctor right away if you have:
- fever, chills, flu symptoms, flushing (heat, redness, or numbness);
- severe joint, bone, or muscle pain;
- new or unusual pain in the hip, thigh or groin;
- a loose tooth, sore mouth, mouth ulcer;
- pale skin, feeling light-headed or short of breath;
- hypocalcemia – numbness or tingly feeling in your fingers or toes or around your mouth, seizures, muscle spasms or cramps;
- signs of a kidney problem – little or no urination; painful or difficult urination; swelling, rapid weight gain; feeling tired or short of breath; or
- Skin backlash – fever, sore throat, swelling of your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially on the face or upper muscles) can) and the causes of blistering and peeling.
Severe side effects on the kidneys may be more likely in older adults.
Common Zometa side effects may include:
- nausea, vomiting, diarrhea, constipation;
- bone, muscle or joint pain;
- fever or other flu symptoms;
- pain in your arms or legs;
- headache, fatigue; or
- shortness of breath.
What other drugs will affect Zometa?
Zometa may harm your kidneys. This effect is increased when you also use a number of other drugs, including: antiviral drugs, chemotherapy, injections of antibiotics, medications for intestinal disorders, medicines to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or medication arthritis (including aspirin, Tylenol, Advil and Aleve).
Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Drug Zometa 4mg / 5ml zoledronic acid cost?
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