Possible Side Effects Of Zoledronic Acid
There are a number of things you can do to manage the side effects of zoledronic acid. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:
Nausea and/or Vomiting
Talk to your doctor or nurse so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods . Try antacids, , saltines, or ginger ale to lessen symptoms.
Low Red Blood Cell Count
Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.
Bone, Joint, and Muscle Pain
Zoledronic acid can cause bone, joint and/or muscle pain that can be severe. This can occur from 1 day to several months after starting the medication. Report these symptoms to your provider, who can advise you on strategies to relieve the pain. Pain in the hip, thigh, and groin can be caused by an atypical femur fracture. Notify your provider immediately of any new pain in this area.
Fatigue
Breathing Difficulties
Less common but important side effects can include:
Reproductive Concerns
About Calcium And Bones
Calcium is a mineral thats stored in your bones, and it helps to keep your bones strong. But throughout your life, your bones are constantly being rebuilt by cells called osteoclasts and osteoblasts.
Osteoclasts break down bone and release calcium into your blood. Osteoblasts repair bone and move calcium from your blood back into your bone. This process helps repair areas of damaged bone and control the level of calcium in your blood.
Drug Forms And Strengths
Zometa comes as a liquid in two different forms:
- Single-dose, ready-to-use bottle. It contains 4 milligrams of the drug in 100 milliliters of liquid solution.
- Single-dose vial. It contains 4 mg of the drug in 5 mL of liquid solution. The solution will be diluted by a healthcare provider before use.
Zometa is given by intravenous infusion. This is an injection into a vein thats given slowly over a period of time. The infusion will be given by a healthcare provider.
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A Drug With Many Uses
Previous trials have shown bisphosphonates might help lower the risk of developing breast cancer in postmenopausal women and reduce recurrence and death in early stage breast cancer patients.
New research out from epidemiologist Dr. Chris Li and others at the Hutch now suggests bisphosphonates may also keep women with ductal carcinoma in situ, or DCIS, from developing invasive disease.
âTwenty percent of all breast cancers are DCIS,â said Li, lead author of the study published last month in the journal Cancer Research. âDCIS has a very high survival rate, but women with a history of DCIS have an elevated risk of developing a subsequent invasive breast cancer. This study suggests that bisphosphonates may lower this risk.â
As this is the first study to report on this relationship, the results will need to be confirmed, Li said it wonât change clinical practice any time soon.
But it does reflect a growing interest in expanding the use of these drugs into another cancer population. And raises important questions about the tradeoffs, the risks vs. benefits, which researchers continue to investigate.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to zoledronic acid.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Drug Forms And Administration
Heres some information about the drug forms for Zometa and Xgeva and how theyre given.
Zometa
Zometa comes as a liquid thats available in two different forms:
- a single-dose, ready-to-use bottle
- a single-dose vial
Zometa is given by intravenous infusion. This is an injection dripped into a vein slowly over a period of time. Zometa infusions are given by a healthcare provider over a period of at least 15 minutes. Its typically done at a healthcare facility, but in some cases, a healthcare provider may give you the drug in your home.
For hypercalcemia caused by cancer, Zometa is given as a single dose. If needed, this may be repeated after 7 days.
For multiple myeloma or cancer thats spread to your bones, Zometa is given once every 3 to 4 weeks.
Xgeva
Xgeva comes as a liquid solution in a single-dose vial. The drug is given as a subcutaneous injection . Youll receive Xgeva in your upper arm, upper thigh, or abdomen. This is typically done in doctors office or clinic. But in some cases, you can receive the injections from a healthcare provider at home or be trained how to give yourself injections.
For all uses, Xgeva is given once every 4 weeks. For giant cell tumors and hypercalcemia caused by cancer, youll also be given extra doses when beginning treatment. These are typically given on days 8 and 15 of the first month of treatment.
Who Might Be Offered Zoledronic Acid
Zoledronic acid is suitable for women who have been through the menopause . It can be used regardless of whether the menopause happened naturally or because of breast cancer treatment.
You may be offered zoledronic acid if you are post-menopausal and have had treatment for invasive breast cancer that has spread to the lymph nodes under the arm.
It may also be considered if you have invasive breast cancer that has not spread to the lymph nodes.
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Analysis Of Absolute Risks
In order to provide absolute risks of adverse events under each treatment , both an odds ratio and a baseline risk are required. Two potential baselines were sought. The first, for women undergoing breast cancer therapy, were taken as the pooled effects from standard meta-analysis of the direct data from the observation only arms of the bisphosphonate trials used in this study, including only studies with the most complete level of reporting. These women were taking a variety of other anti-cancer therapies such as chemotherapy and hormone therapy and so are likely to have relatively high baseline levels of symptoms that could be caused by the cancer or other treatments they were undergoing.
For comparison, suitable absolute risks were sought from trials involving women of a similar demographic who were not suffering from cancer or taking any significant other medications. Searching clinicaltrials.gov for trials with reported results involving postmenopausal women at a high risk of breast cancer and which had a placebo group led us to use data from trial }NCT00083174 , a study of exemestane versus placebo for postmenopausal women at high risk of breast cancer .
Re: Zoledronic Acid Side Effects
Hi Liz
Thanks for this, I think I will go back to them to discuss options. I will await the result of the thyroid test but I am sure these will still be stable and like you say it is probably the low hormone levels. I still think it might be the Zometa, or at least a contributory factor as it has only been a few days since the infusion that I stopped feeling like I had a bad hangover. I still don’t feel 100%, and the anxiety and sleeplessness does not help. My approach to all this is to keep life as normal as possible and try not to over analyse everything you are feeling, but I think maybe I need to see what I can do about these hot flushes and maybe if I slept a bit better I would feel better in myself. Thanks Boo
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Study Selection And Characteristics
The electronic search yielded 505 reports. Of these, 473 were excluded on the basis of the abstract or title, leading to 32 potentially eligible trials. After scrutiny, 13 randomized controlled trials were considered eligible according to the inclusion criteria, whereas hand searches in major meeting abstract books resulted in two additional trials. In total, 15 trials were considered eligible and further analyzed .
Flowchart diagram of study selection.
Baseline characteristics of the eligible trials are presented in Table 1. Five studies allowed the delayed use of zoledronic acid in the control group for individuals who developed osteoporosis. Eight of the eligible trials were designed to only address the role of zoledronic acid in preventing BMD loss. Those studies did not provide any data regarding survival whereas some reported data on fractures. Only seven studies were planned to report survival data as either a primary or secondary outcome. However, all studies included data on ONJ.
Primary Outcome: Os Duration
The primary outcome was assessed in seven studies . However, only five studies either reported HRs or provided data that allowed the calculation of HRs. As shown in Figure 2, zoledronic acid resulted in a statistically significant better OS outcome . No between-study heterogeneity was observed . A subgroup analysis including only trials with an observation arm as the comparator showed that the results remained statistically significant . In addition, a sensitivity analysis with the exclusion of studies with a shorter length of zoledronic acid administration did not alter the statistically significant benefit .
Forest plot for overall survival outcome. Squares represent hazard ratios and size of squares is proportional to the size of the trials. Error bars represent 95% CIs. For all figures, values < 1 indicate that zoledronic acid use has a beneficial effect on outcome.
Abbreviations: ABCSG, Austrian Breast and Colorectal Cancer Study Group AZURE, Adjuvant Zoledronic Acid to Reduce Recurrence CI, confidence interval SE, standard error ZO-FAST, ZometaFemara Adjuvant Synergy Trial.
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Zometa For Other Conditions
In addition to the uses listed above, Zometa may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what its approved for.
And you may wonder if Zometa is used for certain other conditions. Below is information about other possible uses for Zometa.
Zometa for breast cancer
Zometa is sometimes prescribed to people with breast cancer that hasnt spread to other parts of the body. This is an off-label use of the drug.
Bisphosphonates such as Zometa have been shown to reduce the risk of breast cancer spreading to the bones in some people. Zometa can help prevent bone metastases in females* who have gone through menopause, either naturally or following treatment for their cancer.
The American Society of Clinical Oncology recommends that people in this group receive Zometa once every 6 months.
If you have questions about the use of Zometa for breast cancer, talk with your doctor.
* Use of the term male or female in this article refers to a persons sex assigned at birth.
Zometa for osteoporosis
Osteoporosis is a bone disease that causes your bones to become more porous, like honeycomb, and brittle. It results from an increase in bone breakdown and a loss of calcium from your bones. This is called reduced bone mineral density. It makes your bones weak and at risk for fracture. Osteopenia is the stage before osteoporosis when your bones have lost some of their bone mineral density.
Side Effects Of Osteoclast Inhibitors
Comparative studies of intravenous zoledronic acid and subcutaneous denosumab in patients with metastatic breast cancer and prostate cancer reported similar adverse event profiles. Side effects encountered most frequently were acute-phase reactions, nephrotoxicity, hypocalcemia, and osteonecrosis of the jaw . These will be discussed below in more detail. Very rare adverse events in the gastrointestinal tract are seen exclusively during oral bisphosphonate treatment. Following bisphosphonates, there have also been some few reports of ocular complications in terms of scleritis, uveitis, and conjunctivitis . Occasionally, subcutaneous denosumab may induce injection site reactions and other dermatologic conditions such as dermatitis, eczema, and rashes . Rarely, atypical femur fractures have been associated with bisphosphonate and denosumab therapy . So far, no patients have developed detectable levels of neutralizing antibodies against denosumab . In randomized studies of bisphosphonates and denosumab, severe-grade adverse events have occurred with similar frequencies between treatment arms . Likewise, treatment discontinuation secondary to serious side effects was generally similar in patients on zoledronic acid and denosumab .
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Zometa Use With Other Treatments
For multiple myeloma, youll be given Zometa along with your cancer treatment. Your cancer treatment may include chemotherapy, radiation therapy, hormone therapy, or targeted therapy.
Youll also likely take a daily calcium and vitamin D supplement with Zometa. This is to help prevent your calcium level from dropping too low. These supplements should contain 500 milligrams of calcium and 400 international units of vitamin D.
If you have high calcium levels due to cancer, you may receive Zometa with other treatments that help lower the levels. These treatments include:
- Receiving fluids given through a drip into a vein to rehydrate you.
- Taking diuretic medications, such as furosemide . These drugs can help increase urination and remove the excess calcium when you urinate.
Bone Joint Or Muscle Pain With First Treatment
Although mostly a concern for people with metastatic breast cancer who take higher doses of bisphosphonates or denosumab, these drugs can cause bone, joint and muscle pain . This type of pain usually only last for 1-2 days, and only with the first treatment.
However, if you have any of these symptoms, report them to your health care provider right away.
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When To Contact Your Team
Your doctor, nurse, or pharmacist will go through the possible side effects. They will monitor you closely during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:
- you have severe side effects
- your side effects arent getting any better
- your side effects are getting worse
We haven’t listed all the side effects here. Remember it is very unlikely that you will have all of these side effects, but you might have some of them at the same time.
How Cancer Affects Your Bones And Calcium Level
Certain types of cancer can make osteoclasts more active than usual. When osteoclasts are overactive, too much calcium is released from your bones into your blood. A high level of calcium in your blood is called hypercalcemia. This condition can cause symptoms such as:
- urinating more often than usual
If cancer develops in your bones, this can stimulate the osteoclasts and cause hypercalcemia. Cancers that can develop in your bones include multiple myeloma. This is a type of cancer that forms in the bone marrow tissue inside your bones.
Some types of cancer can spread to your bones from other parts of your body. These are called bone metastases. Advanced breast cancer and prostate cancer commonly spread to the bones.
Hypercalcemia can also develop with cancer that isnt in your bones. For example, some types of cancer release certain proteins that flow through your bloodstream. These proteins activate the osteoclasts, causing calcium to be released into your blood. This occurs in various types of cancer, including:
If you lose too much calcium from your bones, they can become weak and likely to fracture. And if you have cancer growing in your bones, this can cause your bones to have further damage, weakness, and pain.
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Osteonecrosis Of The Jaw
An uncommon but serious side effect of bisphosphate use is osteonecrosis of the jaw . This refers to the destruction of bone in either the mandible or maxilla . Serious cases may require the surgical removal of damaged bone and marrow.
ONJ may affect up to 2 percent of bisphosphonate users. The vast majority develop after an invasive dental procedure, such as tooth extraction. Advanced breast cancer, poor oral health, and the concurrent use of chemotherapy or corticosteroids may also contribute to the risk.
ONJ is far more common with injectable bisphosphonates like Zometa than with oral ones.
Before starting Zometa or Bonefos, schedule a dental exam to check for gum disease. If you require an invasive dental procedure, have it performed before starting bisphosphonate therapy.
Side Effects And Risks
Zometa and Xgeva can cause some similar side effects, but some different ones as well. Below are examples of these side effects.
Mild side effects
These lists contain up to 10 of the most common mild side effects that can occur with either Zometa or Xgeva, as well as mild side effects that both drugs may share.
- Can occur with Zometa:
Serious side effects
These lists contain examples of serious side effects that can occur with either Zometa or Xgeva, as well as serious side effects that both drugs may share.
- Can occur with Zometa:
- kidney problems, such as reduced kidney function or kidney failure
- hypercalcemia , after stopping treatment
- osteonecrosis of the jaw
- atypical femur fracture
- severe bone, joint, or muscle pain
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