วันเสาร์ที่ 19 กรกฎาคม พ.ศ. 2557

Changes to the Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) labeling

On June 5, 2014, FDA approved changes to the  Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) fixed-dose combination tablet labeling to include rilpivirine dose adjustment information when Complera is coadministered with rifabutin.
If Complera is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with Complera and with a meal for the duration of the rifabutin coadministration.
With these new dosing recommendations, rifabutin was removed from the CONTRAINDICATIONS section.
The revised labeling will be posted soon on the Drugs@FDA web page.
Complera is a product of Gilead Sciences, Inc.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

วันอาทิตย์ที่ 6 กรกฎาคม พ.ศ. 2557

ATRIPLA

ADDITIONAL IMPORTANT SAFETY INFORMATION for
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)

Who should not take ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?
You and your healthcare provider should decide if ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients.
What should I tell my healthcare provider before taking
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?
Tell your healthcare provider if you:
  • Are pregnant or planning to become pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective.
  • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV and some of the medicines in ATRIPLA through their milk to the baby. We do not know if ATRIPLA could harm your baby.
  • Have kidney problems or are undergoing kidney dialysis treatment
  • Have bone problems
  • Have liver problems, including hepatitis B or C virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine.
  • Have ever had mental illness or are using drugs or alcohol
  • Have ever had seizures or are taking medicine for seizures. Seizures have occurred in patients taking efavirenz, a component of ATRIPLA, generally in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.
What important information should I know about taking other medicines with
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?
ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses.
MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA
  • Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil)Propulsid® (cisapride),Versed® (midazolam)Orap® (pimozide)Halcion® (triazolam), or ergot medications (for example, Wigraine® and Cafergot®).
  • ATRIPLA should not be taken with: Combivir® (lamivudine/zidovudine),
    COMPLERA® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate),
    EMTRIVA® (emtricitabine), Epivir® or Epivir-HBV® (lamivudine),
    Epzicom® (abacavir sulfate/lamivudine),
    STRIBILD® (elvitegravir/cobicistat/emtricitabine/tenofovir DF),
    Trizivir® (abacavir sulfate/lamivudine/zidovudine),
    TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with
    SUSTIVA® (efavirenz) unless recommended by your healthcare provider.
  • Vfend® (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA.
  • Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs.
  • ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil).
These are not all the medicines that may cause problems if you take ATRIPLA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
What are the possible side effects of
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?
ATRIPLA may cause the following additional serious side effects:
  • Serious psychiatric problems. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
  • Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
  • Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
  • Changes in bone mineral density (thinning bones). Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia), which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to do tests to check your bones or may prescribe medicines to help your bones. Also, bone pain and bone softening may occur because of kidney problems.
Common side effects:
  • Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach; they tend to go away after taking ATRIPLA for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if ATRIPLA is used with alcohol and/ormood-altering (street) drugs.
  • If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
  • Rash is a common side effect with ATRIPLA that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call your healthcare provider right away.
  • Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.
Other possible side effects:
  • Changes in body fat have been seen in some people taking anti-HIV-1 medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these changes in body fat are not known.
  • Skin discoloration (small spots or freckles) may also happen.
  • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. If you notice any symptoms of infection, contact your healthcare provider right away.
  • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.
This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate).
You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.
Please see Full Prescribing Information, including “What is the most important information I should know about ATRIPLA” in the Patient Information section.

วันอาทิตย์ที่ 22 กันยายน พ.ศ. 2556

A new drug to treat HIV infection was approved by the U.S. Food and Drug Administration on Monday.
Marketed as Tivicay, the medication interferes with an enzyme that is essential to the ability of the HIV virus to multiply and spread within the human body, the agency said in a news release. It is a pill that is to be taken once a day with other HIV drugs, according to the FDA.
"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."
Approved for use in both people who have been diagnosed with HIV but have never taken medications to treat the virus and in those who have taken other HIV drugs, Tivicay (dolutegravir) is also approved for certain children under the age of 12.
The approval was based on the results of five clinical trials involving more than 2,500 patients. Insomnia and headaches were common side effects of the medication, along with hypersensitivity and abnormal liver function in HIV patients who have also been diagnosed with hepatitis B and/or C, the agency said in the release.
Almost 50,000 Americans are infected with HIV every year, according to the U.S. Centers for Disease Control and Prevention, and more than 15,000 died of the disease in 2010.
Tivicay is made by GlaxoSmithKline, based in Research Triangle Park, N.C., according to the FDA.

วันเสาร์ที่ 18 พฤษภาคม พ.ศ. 2556

WHO RISK ASSESSMENT Human infections with influenza A(H7N9) virus 13April 2013


WHO RISK ASSESSMENT
Human infections with influenza A(H7N9) virus
13April 2013
Summary of available information
As of 13April 2013, a total of 49 confirmed cases of human infection with avian influenza A(H7N9)
virus have been reported to WHO by the China National Health and Family Planning Commission.
Among these cases, the ages range from 4 to 87; 15 are female. Eleven persons have died, and the
majority of the additional cases are considered severe. Of the 49 cases, 6 have been reported today
and further investigations are taking place. The cases have been reported from three provinces:
Anhui, Jiangsu and Zhejiang, and two municipalities, Beijing and Shanghai. All locations are in Eastern
and Northern China.
Two confirmed cases have been associated with possible family clusters, in which one and two
additional family members,respectively, developed severe pneumonia. Close contacts of confirmed
cases and health care workers caring for cases have been monitored for infection. So far, among the
contacts who have been tested by polymerase chain reaction, none has been shown to have
infection.
This is the first time human infection with this influenza subtype, avian influenza A(H7N9) virus, has
been detected. Previously,sporadic cases of human infection with otherinfluenza A(H7) viruses
have been reported. Those cases were associated with outbreaks of infection in poultry in other
countries. These earlierinfluenza A(H7) human infections generally resulted in mild influenza illness
with some conjunctivitis.
Genetic and laboratory characterization of the first three of these H7N9 virusesisolated from
humans indicatesthat:

• the virus contains a group of avian influenza virus genes from three different avian influenza
viruses;
• to date, genetic analyses of the isolates have shown certain changes, including amino acid
substitutions associated with increased affinity to alpha 2-6 receptors, which suggests that
the H7N9 virus may have greater ability to infect mammalian species, including humans,
than most other avian influenza viruses;
• there are sequence variations among the genes of three isolates that suggestthere has been
more than one introduction of this virus from animal into humans;
• these viruses are expected to be sensitive to the neuraminidase inhibitor drugs oseltamivir
and zanamivir, but resistant to the antiviral drugs amantadine and rimantadine;
• the isolates have a haemagglutinin structure thatis associated with low pathogenicity in
birds.
There are several gaps in critical information at this time, including the animal reservoir(s)in which
this virus is circulating, the main exposures and routes of transmission for how human infections
have been acquired, and the current scope of the spread of this virus among animal and human
populations. Avian influenza A(H7N9) viruses have now been isolated from poultry (including duck)
and pigeon in the live birdmarketsin some areas of China, but whether other potential reservoirs of

this virus may exist, including in other domestic and wild bird species, and mammalian species such
as pigs, has not yet been determined clearly.
So far, this virus has not been associated with reports of severe disease in poultry.
Risk assessment
This initial risk assessment, which has been prepared in accordance withWHO’s published
recommendations for rapid risk assessment of acute public health events1
will be updated as further
information becomes available.
What is the risk of the occurrence of further cases in the affected areas of China and other areas?
The epidemiology of this virus among animals, including the main reservoirs of infection among
animals and the extent of geographic spread, is not yet established. However, it is likely that most
human H7N9 infections so far are associated with infection among as-of-yet undetermined animals
and that further human cases of infection should be expected.
What is the risk of human-to-human transmission?

There is no evidence of sustained human-to-human transmission. However the two possible family
clusters suggestthat limited human-to-human transmissionmay occur where there is close contact
between cases and other individuals, as occurs in families and, potentially, healthcare settings.
Moreover, the genetic changes seen among these viruses suggesting adaptation to mammals is of
concern, and further adaptation may occur.
What isthe risk of international spread?
At this time, there is no information to indicate international spread of this virus. However, it is
possible that an infected person, who may or may not have symptoms, could travel to another
country. However, if the virus cannot sustain human-to-human transmission, as appears to be the
current situation, then extensive community spread is unlikely.
WHO does not advise special screening at points of entry with regard to this event, nor does it
recommend that any travel or trade restrictions be applied.


References
Most recent disease outbreak news can be found at:
http://www.who.int/csr/don/en/index.html
Background and summary of human infection with influenza A(H7N9) virus (as of 5 April 2013):
http://www.who.int/influenza/human_animal_interface/update_20130405/en/index.html
Frequently Asked Questions on human infection with influenza A(H7N9) virus, China:
http://www.who.int/influenza/human_animal_interface/faq_H7N9/en/index.html





Human infection with a new type of influenza virus A(H7N9)

The World Health Organization (WHO) has been officially notified by the China National Health and Family Planning Commission about human infection (and deaths) with an influenza virus subtype A(H7N9) that has not been previously reported in humans. There is no indication of human-to-human transmission associated with these patients. WHO is working closely with it's Collaborating Centres for influenza to discuss and strengthen diagnostics and case management. At present, the reservoir, source of infection and mode of transmission remain unknown.