Zofrex Side effects

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What are the possible side effects of Zofrex?

Get emergency medical help if you have any signs of an allergic reaction to Zofrex: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Serious side effects on the kidneys may be more likely in older adults.

Common Zofrex side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Zofrex in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Postmenopausal Osteoporosis: In HORIZON-PFT, the Phase III randomized, double-blind, placebo-controlled, multinational study of 7736 women aged 65-89 years, there were no significant differences in the overall incidence of serious adverse events compared to placebo and most adverse events were mild to moderate. Zofrex was administered once yearly for 3 consecutive years for a total of 3 doses.

Consistent with the IV administration of bisphosphonates, Zofrex has been most commonly associated with the following post-dose symptoms: Fever (18.1%), myalgia (9.4%), flu-like symptoms (7.8%), arthralgia (6.8%) and headache (6.5%), the majority of which occur within the first 3 days following Zofrex administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms decreased markedly with subsequent doses of Zofrex.

The incidence of post-dose symptoms occurring within the first 3 days after administration of Zofrex, can be reduced by approximately 50% with the administration of paracetamol or ibuprofen shortly following Zofrex administration.

Very common (≥1/10), common (≥1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/1000, <1/10,000) adverse reactions suspected (investigator assessment) to be associated with Zofrex are shown as follows: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse drug reactions suspected* (at least 1%) to be associated with Zofrex in postmenopausal osteoporosis in HORIZON-PFT study:

Nervous System Disorders: Common: Headache, dizziness. Uncommon: Lethargyb, paresthesia, somnolence, tremor, syncope, dysgeusia.

Eye Disorders: Uncommon: Conjunctivitis, eye pain, uveitis. Rare: Episcleritis, iritis.

Ear and Labyrinth Disorders: Uncommon: Vertigo.

Respiratory, Thoracic and Mediastinal Disorders: Common: Dyspneaa.

Gastrointestinal Disorders: Common: Nausea, vomiting, diarrhea. Uncommon: Dyspepsiab, abdominal pain, dry mouth, esophagitis.

Skin and Subcutaneous Tissue Disorders: Uncommon: Rash.

Musculoskeletal Disorders: Common: Myalgia, arthralgia, bone pain, back pain, pain in extremity. Uncommon: Joint swelling.

Renal and Urinary Disorders: Uncommon: Increase blood creatinine.

General Disorders and Administration Site Conditions: Very common: Fever. Common: Hypocalcemiaa, flu-like symptomsc, chills, fatigue, asthenia, pain, malaise, rigorsa. Uncommon: Anorexia, peripheral edema, thirst.

*Incidence based on investigator assessment of causality and includes those events with a greater frequency than placebo.

Key deviations in the adverse events in the Paget's disease clinical trials compared to the postmenopausal HORIZON-PFT trial are summarized as follows:

a Common in Paget's disease only.

b Common in Paget's disease.

c Very common in Paget's disease.

In one 3-year trial in postmenopausal osteoporosis women (HORIZON-PFT), the overall incidence of atrial fibrillation was low, reported in 2.5% of patients (96 out of 3862) in the Zofrex group versus 1.9% of patients (75 out of 3852) in the placebo group. The increased incidence observed in this trial has not been observed in other clinical trials with Zofrex.

Class Effects: Renal Dysfunction: Treatment with IV bisphosphonates, including Zofrex, has been associated with renal dysfunction manifested as deterioration in renal function (ie, increased serum creatinine) and in rare cases, acute renal failure. Renal dysfunction has been observed following the administration of Zofrex, especially in patients with preexisting renal compromise or additional risk factors (eg, oncology patients with chemotherapy, concomitant nephrotoxic medications, severe dehydration), the majority of whom received a 4-mg dose every 3-4 weeks, but it has been observed in patients after a single administration.

In the HORIZON-PFT trial, the change in creatinine clearance (measured annually prior to dosing), and the incidence of renal failure and impairment was comparable for both the Zofrex and placebo treatment groups over 3 years. There was a transient increase in serum creatinine observed within 10 days in 1.8% of Zofrex-treated patients versus 0.8% of placebo-treated patients.

Laboratory Findings: In the HORIZON-PFT trial, approximately 0.2% of patients had notable declines of serum calcium levels (<1.87 mmol/L) following Zofrex administration. No symptomatic cases of hypocalcemia were observed.

In the Paget's disease trials, symptomatic hypocalcemia was observed in approximately 1% of patients, all of which resolved.

Local Reactions: Local reactions at the infusion site eg, redness, swelling and/or pain were reported (0.7%) following the administration of Zofrex.

Osteonecrosis of the Jaw: Cases of osteonecrosis (primarily of the jaw) have been reported predominantly in cancer patients treated with bisphosphonates, including Zofrex (uncommon). Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (eg, chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (eg, anemia, coagulopathies, infection, preexisting dental disease). Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged. In the HORIZON-PFT trial in 7736 patients, ONJ has been reported in 1 patient treated with Zofrex and 2 patients treated with placebo. All 3 cases resolved.

What is the most important information I should know about Zofrex?

Zofrex contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Zofrex can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys, such as: chemotherapy, antiviral medication, pain or arthritis medicine, injected antibiotics, or medicines to treat a bowel disorder or prevent organ transplant rejection. You may need dose adjustments or special tests if you use any of these medications.

Do not receive Zofrex without telling your doctor if you have had an allergic reaction to Zofrex or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

Do not use Zofrex if you are pregnant. It could harm the unborn baby.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zofrex. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Zofrex have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. 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 blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with Zofrex. It may take longer than normal for you to recover.


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References

  1. DailyMed. "ZOLEDRONIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "Zoledronic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. NCIt. "Zoledronic Acid Anhydrous: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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