Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Lexiva (fosamprenavir calcium) Tablets

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PRECAUTIONS

• Immune Reconstitution Syndrome
• Drug Interactions
  • Table 13: Established and Other Potentially Significant Drug Interactions.....
    • Antidepressant
      • Trazodone
    • Inhaled/Nasal Steroid
      • Fluticasone

A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone propionate exposures, resulting in significantly decreased serum cortisol concentrations. Concomitant use of Lexiva with ritonavir and fluticasone propionate is expected to produce the same effects. Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported during postmarketing use in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate.....

Nolvadex (tamoxifen citrate) Tablets

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• Thromboembolic Effects of Nolvadex

PRECAUTIONS

• Laboratory Tests
• Drug Interactions
  • Based on clinical and pharmacokinetic results from the anastrozole adjuvant trial, Nolvadex should not be administered with anastrozole.....
• Nursing Mothers
• Reduction in Breast Cancer Incidence in High Risk Women with DCIS

ADVERSE REACTIONS

• Adjuvant Breast Cancer
  • Anastrozole Adjuvant Trial - Study of Anastrozole compared to Nolvadex for Adjuvant Treatment of Early Breast Cancer.....

Ontak (denileukin diftitox)

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• Visual Loss

ADVERSE REACTIONS

• Postmarketing
  • Special Senses
    • Visual Loss

Loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported following administration of Ontak. Recovery was reported in some of the affected patients; however, most patients reported persistent visual impairment.

For additional details, see MedWatch 3/15/06 Safety Alert.  

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PRECAUTIONS

• Pediatric Patients

ADVERSE REACTIONS

• Heart Transplantation

See prescribing information for WARNINGS related to use of Prograf in the prophylaxis of organ rejection in patients receiving allogeneic heart transplants.

Relenza (zanamivir for inhalation)

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PRECAUTIONS

• Prevention of Influenza

• Information for Patients
  • Patients should be advised of the risk of bronchospasm.....
• Pediatric Use
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph
• Prophylaxis of Influenza: Family/Household Prophylaxis Studies
  • Table 3: Summary of Adverse Events.....
• Community Prophylaxis Studies
  • Table 4: Summary of Adverse Events.....

PATIENT PACKAGE INSERT

Relenza is not recommended for treatment or prophylaxis of influenza in individuals with underlying airway disease (such as asthma or chronic obstructive pulmonary disease).

Serious cases of bronchospasm, including fatalities, have been reported during treatment with Relenza in patients with and without underlying airways disease. Many of these cases were reported during postmarketing and causality was difficult to assess.

Relenza should be discontinued in any patient who develops bronchospasm or decline in respiratory function; immediate treatment and hospitalization may be required. Some patients without prior pulmonary disease may also have respiratory abnormalities from acute respiratory infection that could resemble adverse drug reactions or increase patient vulnerability to adverse drug reactions.....

Septocaine with epinephrine 1:100,000   

Septocaine with epinephrine 1:200,000

ADVERSE REACTIONS

• .....Table 2 displays the adverse events reported in clinical trials where 182 individuals were exposed to Septocaine with epinephrine 1:100,000 and 179 individuals were exposed to Septocaine with epinephrine 1:200,000.
• Table 2:  Adverse Events in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Septocaine.....
• Body as a Whole
  • Burning Sensation Above Injection Site
• Cardiovascular System
  • Elevated Blood Pressure
• Nervous System
  • Exacerbation of Kearns-Sayre Syndrome
• Respiratory System
  • Sinus Pain
  • Sinus Congestion

Septocaine, along with other local anesthetics, are capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.

Taxotere (docetaxel) Injection Concentrate

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• Hematologic Effects

• Geriatric Use
  • Among the 221 patients treated with Taxotere.....

• Initial Paragraph
  • In the treatment of advanced gastric adenocarcinoma in patients.....
• Combination Therapy with Taxotere in Gastric Adenocarcinoma

.....In gastric cancer patients treated with Taxotere in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving G-CSF compared to 28% who did not. Patients receiving TCF should be closely monitored during the first and subsequent cycles for febrile neutropenia and neutropenic infection.

Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets

• Other

ADVERSE REACTIONS

• Clinical Trials
  • Truvada
    • Study 934 - Treatment Emergent Adverse Events
      • Table 8: Selected Treatment-Emergent Adverse Events (Grades 2-4) Reported in ≥3%.....
      • Laboratory Abnormalities
      • Table 9: Significant Laboratory Abnormalities Reported in ≥1%....

Truvada is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. Truvada should not be coadministered with Emtriva or Viread. Due to similarities between emtricitabine and lamivudine, Truvada should not be coadministered with other drugs containing lamivudine, including Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir.

Viread (tenofovir disoproxil fumarate) Tablets

• Other

ADVERSE REACTIONS

• Clinical Trials
  • Treatment-Naïve Patients
    • Study 934 - Treatment Emergent Adverse Events
    • Table 11: Selected Treatment-Emergent Adverse Events.....
    • Laboratory Abnormalities
    • Table 12: Significant Laboratory Abnormalities....

Viread should not be used in combination with the fixed-dose combination product Truvada since it is a component of that product.

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• Clinical Worsening and Suicide Risk

.....In addition, patients with a history of suicidal behavior or thoughts, those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.