Author Archives: akrom

About akrom

Lahir di salah satu desa di kota terkecil "Pati" (menurut kepala sekolah waktu SD) pada tahun 1967, maklum karena waktu itu ditemapat saya belum musimnya menggunakan akte kelahiran untuk bukti pencantuman tanggal lahir siswa diijazah, sehingga tanggal lahir sesuai belas kasihan kepala sekolah yang mengeluarkan ijazah SD saya. Sekolah di SMPN1 Winong, sekolah unggulan di kota kecamatan Winong waktu itu. Setelah lulus SMP melanjutkan di SMA1 N Pati, juga salah satu sekolah SMA terfaforit di kota Pati. Akhirnya kuliahnya tersangkut UMPTN di Farmasi UGM, kesasar di KIMIA Mipa UGM dua tahun dan berakhir di Fakultas Kedokteran UGM. Sudah berkeluarga, dengan enam keturunan, hanya saja salah satunya sudah diminta kembali oleh Sang Maha Kuasa, bair jadi tabungan kami kelak, semoga. Istri juga seorang dokter, yang sangat rajin ngoyak-ngoyak anak-anak untuk belajar sambil praktek di rumah. Baik saya maupun istri, pernah kerja di di beberapa RS tetapi kemudian kami berdua meneguhkan diri di lembaga pendidikan untuk mengabdikan ilmu di pendidikan. Semoga bermanfaat.

masihkah ada harapan sembuh bagi penderita DM tipe I?

Penyakit gula akibat kerusakan pankreas yang sering dialami sejak usia anak-anak merupakan penyakit autoimun. Upaya pencarian obat untuk penyakit gula ini senantiasa dilakukan, karena penderita penyakit ini bila organ pankresnya tidak membaik maka mereka membutuhkan insulin seumur hidupnya, tentu itu akan berhubungan dengan biaya, risiko ketidaknyamanan dalam cara pemberian insulin, reaksi penolakan atau adanya komplikasi. Baru-baru ini NEJM melaporkan hasil penelitian klinik obat baru bagi penderita baru DM tipe I yang berjudul” GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus” namun penelitian ini masih belum memberikan hasil sebagaimana yang diharapkan. Hasil selengkapnya abstrak laporan tersebut silakan baca pada kopian sbb:GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus

Johnny Ludvigsson, M.D., Ph.D., David Krisky, M.D., Ph.D., Rosaura Casas, Ph.D., Tadej Battelino, M.D., Ph.D., Luis Castaño, M.D., Ph.D., James Greening, M.D., Olga Kordonouri, M.D., Timo Otonkoski, M.D., Ph.D., Paolo Pozzilli, M.D., Jean-Jacques Robert, M.D., Ph.D., Henk J. Veeze, M.D., Ph.D., and Jerry Palmer, M.D.

N Engl J Med 2012; 366:433-442February 2, 2012


The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes.

Full Text of Background…

We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels.

Full Text of Methods…

The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences.

Full Text of Results…

Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; number, NCT00723411.)

imatinib mesylate tablet, untuk apakah?

FDA telah mengeluarkan ijin untuk penggunaan imatinib mesylate secara oral.
Obat ini cukup lusas penggunaannya di kedokteran. Berita selengkapnya silakan baca pada artikel berikut:
Imatinib Mesylate Tablets

On January 31, 2012, the U.S. Food and Drug Administration (FDA) granted regular approval for imatinib mesylate tablets (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST). Accelerated approval for this indication was granted in December 2008. Labeling is also revised to include the results of a randomized trial demonstrating that recurrence-free survival (RFS) and overall survival (OS) were improved by continuing adjuvant imatinib therapy to 36 months.

An adjuvant, multicenter, open label, phase 3 trial randomly allocated patients to receive either 12 or 36 months of imatinib treatment. Patients received imatinib, 400 mg orally daily, in both treatment duration arms.

Eligible patients had one of the following criteria: tumor diameter >5 cm and mitotic count >5/50 high power fields (HPF), or tumor diameter >10 cm and any mitotic count, or tumor of any size with mitotic count >10/50 HPF, or tumors that ruptured into the peritoneal cavity. There were 199 patients on the 12-month arm and 198 patients on the 36-month arm. The median age of patients was 61 years (range, 22-84 years).

RFS was defined as the time from date of randomization to the date of recurrence or death from any cause. The median follow-up for patients without a RFS event was 42 months. There were 84 (42%) RFS events in the 12-month treatment arm and 50 (25%) RFS events in the 36-month treatment arm. Thirty-six months of imatinib treatment significantly prolonged RFS compared to 12 months [HR=0.46, (95% CI: 0.32, 0.65), p

The median follow-up for OS in patients still alive was 48 months. There were 25 (13%) deaths in the 12-month treatment arm and 12 (6%) deaths in the 36-month treatment arm. Thirty-six months of imatinib treatment significantly prolonged OS compared to 12 months [HR=0.45, (95% CI: 0.22, 0.89), p=0.0187].

Discontinuation of imatinib therapy due to adverse reactions occurred in 15 patients (8%) and 27 patients (14%) of the 12- and 36-month treatment arms, respectively. The most common adverse reactions, as noted in this and previous imatinib trials, were swelling (edema), nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

imatinib mesylate

imatinib mesylat

Imatinib received accelerated approval for patients with Kit (CD117) positive unresectable and/or metastatic GIST in February 2002. This indication subsequently received regular approval in September 2008.

The recommended dose of imatinib for adjuvant treatment is 400 mg/day administered with meals daily for three years. The optimal duration of treatment is not known.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Bagaimana perkambangan ilmu dan teknologi kesehatan untuk masalah fibrosis uterus?

Fibroid uterin sudah menjadi masalah kesehatan sejak jaman purbakala namun sampai saat ini masih meninggalkan banyak masalah. Pada terbitan edisi minggu ini NEJM bagian editorialnya membahas masalah fibroid uterin. Judul yang dipilih pada editorial nejm tersebut adalah”Uterine Fibroids and Evidence-Based Medicine — Not an Oxymoron”. bagaimana paparan editorial ini? silakan kutipan selengkapnya sebagai berikut:

Elizabeth A. Stewart, M.D.

N Engl J Med 2012; 366:471-473February 2, 2012


The 2011 report from the Agency for Healthcare Research and Quality on comparative management of uterine fibroids noted, “Despite the prevalence and possible complications of uterine fibroids, few published studies examining the effectiveness of treatment strategies exist.”1 Few therapies are approved by the Food and Drug Administration (FDA) for fibroids; leuprolide acetate, a gonadotropin-releasing hormone (GnRH) agonist, was approved in 1995 for preoperative treatment of fibroids, with the addition of iron. In the past decade, uterine-artery embolization and magnetic-resonance–guided focused ultrasound surgery have also been therapeutic options. Surgeries for fibroids, especially hysterectomy, still predominate, and fibroids remain the leading cause of hysterectomy.2

Whereas estrogen was long considered to be the key factor in the pathogenesis of fibroids,3 it has been recognized more recently that progesterone also plays a critical role, as do inherited and somatic mutations, growth-factor dysregulation, and an active extracellular matrix.2 Several studies, including relatively small, randomized clinical trials, have supported the safety and efficacy of selective progesterone-receptor modulators in reducing uterine volume and controlling menstrual bleeding.4-6 However, this class of agent has not been approved for the treatment of fibroids, in part because of political issues surrounding the use of mifepristone.7

In this issue of the Journal, Donnez et al. report the results of two randomized clinical trials that support the efficacy of the progesterone-receptor modulator ulipristal acetate for preoperative treatment of symptomatic uterine fibroids.8,9 In one report, two doses of ulipristal acetate were compared with placebo among women with anemia; all the women in this trial also received iron supplementation.8 In the second, the same doses of ulipristal acetate were compared in a noninferiority trial with leuprolide acetate9; women in this trial received iron supplementation at the discretion of the treating physician. GnRH agonists are highly effective for the treatment of fibroids because they induce amenorrhea, resulting in cessation of heavy menstrual periods, and a reduction in fibroid volume, resulting in relief of symptoms related to leiomyoma bulk.3 However, GnRH agonists cause severe hypoestrogenic symptoms and long-term effects on bone density, thus limiting the safety and negatively affecting the side-effect profile of the drugs.

Ulipristal acetate was superior to placebo and noninferior to leuprolide acetate for the control of bleeding; more than 90% of the women treated with either dose of ulipristal acetate had a clinically significant decrease in bleeding, and approximately three fourths became amenorrheic. In addition, there was no initial steroidal flare with ulipristal acetate as there is with leuprolide acetate — an advantage for women with excessive menses and anemia. Ulipristal acetate induced amenorrhea more quickly than did leuprolide acetate and resulted in a greater increase in hemoglobin level than did placebo, although iron supplementation alone has been shown to be quite effective for the preoperative management of anemia.10

For symptoms related to leiomyoma bulk, leuprolide acetate appeared to be more effective than ulipristal acetate, resulting in a greater reduction in fibroid volume. However, data in the Supplementary Appendix (available with the full text of the article at on the subset of women who did not undergo surgery support the results of prior studies that suggest that progesterone-receptor modulators provide more prolonged volume reduction after treatment is discontinued, as compared with the rapid regrowth seen after discontinuation of GnRH agonist therapy.4

There were no major safety concerns with ulipristal acetate in these short-term studies. Ulipristal acetate had a better side-effect profile than did leuprolide acetate, with less profound suppression of estradiol levels, significantly fewer hot flashes, and few substantial effects on markers of bone turnover.9

The trials also shed some light on the major potential safety issue with progesterone-receptor modulators — their effect on the endometrium. Since progestins protect against estrogen-induced proliferation of endometrium, the question remains whether long-term use of progesterone-receptor modulators might lead to endometrial hyperplasia or carcinoma. Therapy with progesterone-receptor modulators causes a unique nonphysiologic pattern of endometrial changes with glandular dilatation and dyssynchronous changes between the glands and stroma, which have some hallmarks of malignant change but which, on intensive study, appear to be benign.11

In approximately 60% of the women in these trials who were treated with ulipristal acetate, endometrial biopsy samples showed changes typically associated with progesterone-receptor modulators after 3 months of therapy, but these changes resolved after a 6-month drug-free period.8 If longer-term studies confirm a carryover effect of progesterone-receptor modulators on reduction of uterine volume, as well as resolution of endometrial changes, women with symptomatic fibroids may have the option of a unique intermittent therapy that maximizes efficacy while minimizing safety concerns.

Several limitations of the current studies, in addition to the short duration of treatment, should be noted. Few black women were included, yet black women have a greater risk of fibroids, a more severe phenotype, and an earlier age of onset than do white women.2 This lack of diversity is unfortunately common in clinical trials of treatments for fibroids.12 Participants in these trials also tended to be thinner than the general population of women with fibroids, and their uteri were only moderately enlarged as compared with the uteri in women in other trials of innovative fibroid therapies.13,14 Women were not screened for ovulatory function, and thus leiomyomas may not be the sole explanation for bleeding in the women.

Studies of progesterone-receptor modulators as treatment for fibroids date back almost two decades. Since that time, innovations in interventional therapies have provided effective, minimally invasive alternatives to hysterectomy. Unfortunately, the rate of hysterectomy continues to be high,15 and there remains substantial need for effective medical therapy.2 The present studies represent an important step in that direction.

Kalydeco, obat baru untuk penderita cystic fibrosis

Meskipun penyakit yang satu ini cukup jarang kejadiaannya di masyarakat, tetapi sangat berbahaya.Kelainan genetik yang menyebabkan kerusakan dan gangguan fungsi paru, pankreas dan berbagai organ vital lainnya, biasanya akan berakhir dengan kematian.Direleasenya obat baru ini oleh FDA tentu memberikan harapan besar bagi masa depan penderita cystic fibrosis. Selama ini memang sudah ada terapi obat untuk kelainan ini tetapi belum juga definitf dan hasilnya belum memuaskan. Selamat semoga bermanfaat. Berita selengkapnya silakan baca pada lintasan berita berikut:FDA approves Kalydeco to treat rare form of cystic fibrosis
Breakthrough therapy targets defective protein

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”

The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug’s April 18, 2012 prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

Kalydeco is manufactured by Vertex Pharmaceuticals Inc. of Cambridge, Mass.

FDA merelease obat baru lagi, Vismodegib, obat ca sel basalis metastasis

Vismodegib merupakan obat untuk karsinoma sel basal metastasis atau kanker kulit sel basal fase lanjut yang tidak memungkinkan untu pembedahan atau kekambuhan pasca terapi pembedahan.

Prinsip kerja dari kerja obat baru ini adalah mempengaruhi signaling pada bagian subseluler yang disebut sistem signaling “hedgehog pathway”. Sebagaimana tampak pada gambar

hedgehog pathway

Berita lengkap tentang obat baru ini silakan baca pada paparan berikut:

On January 30, 2012, the U. S. Food and Drug Administration approved vismodegib (ERIVEDGE Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

obat kanker sel basalis


Efficacy was demonstrated in a single-arm, parallel cohort trial enrolling 104 patients. Patients received 150 mg of vismodegib daily. Central pathologic review of archival or baseline tissue confirmed the diagnosis of basal cell carcinoma (BCC) in 96 patients: 33 patients with metastatic basal cell carcinoma (mBCC) and 63 patients with locally advanced basal cell carcinoma (laBCC).

Efficacy was evaluated in these 96 patients with confirmed BCC. The median age of this population was 62 years, 61% were male, and 97% had an ECOG performance status of 0 or 1. Twenty‑one percent of patients carried a diagnosis of Gorlin syndrome. Sixty-six percent had locally advanced disease; 34% had metastatic disease. Among those with mBCC, 97% were previously treated. Prior therapy included surgery (97%), radiotherapy (58%), and systemic therapies (30%). Among laBCC patients, 94% were previously treated. Prior therapies included surgery (89%), radiotherapy (27%), and systemic/topical therapies (11%).

The trial’s primary endpoint was objective response rate (ORR) assessed by an independent review facility. Tumor response criteria for laBCC included assessment of tumor size, the presence or absence of ulceration, and biopsy of local disease sites. The criteria for complete response in localized disease required tumor biopsy (ies) demonstrating no pathologic evidence of BCC. RECIST version 1.0 criteria were used to assess responses in the mBCC population.

The ORRs were 30.3% (95% CI: 15.6, 48.2) and 42.9% (95% CI: 30.5, 56.0) in patients with mBCC and laBCC, respectively. All responses in the mBCC cohort were partial responses. For the 63 evaluable patients with laBCC, 13 (20.6%) patients had complete responses and 14 (22.2%) had partial responses. The median response duration was 7.6 months (95% CI: 5.6, not estimable) and 7.6 months (95% CI: 5.6, 9.7) for patients with mBCC and laBCC, respectively.

Safety was evaluated in 138 patients who received vismodegib as monotherapy for laBCC or mBCC. Adverse reactions occurring in more than 10% of patients were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea. Grade 3 adverse reactions occurring in more than 1% of patients were weight loss, fatigue, muscle spasms, and decreased appetite.

Healthcare professionals should verify pregnancy status prior to the initiation of vismodegib, counsel pregnant women on the potential risks to the embryo/fetus, and advise non-pregnant women to use highly effective contraception during treatment with vismodegib and for up to 7 months after the last dose. To avoid exposing an embryo/fetus to vismodegib that may be contained in semen, male patients should use condoms with spermicide during treatment with vismodegib, and for 2 months after the last dose. Healthcare providers should report to Genentech any cases of exposure during pregnancy (either direct exposure in female patients or through seminal fluid from male patients), and should encourage pregnant women to participate in the Erivedge pregnancy pharmacogvigilance program to collect information on pregnancy outcomes.

Vismodegib inhibits the Hedgehog pathway, an important embryonic developmental pathway. Reproductive toxicology studies in rats demonstrated that vismodegib exposure during organogensis results in embryo-fetal death at higher exposures and severe birth defects at exposures within the range achieved with the recommended human dose.

The recommended dose and schedule for vismodegib is 150 mg orally daily. Vismodegib may be taken with or without food.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:[download id=”1″]

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

apakah bevacizumab itu? avastin adalah contoh produk paten bevacizumab

Avastin is a cancer medicine that interferes with the growth of cancer cells by blocking the formation and growth of new blood vessels in the tumor which slows their growth.

obat biologis anti ca mamae

Avastin is used to treat a certain type of brain tumor as well as cancers of the kidney, colon, rectum, lung, or breast. It is usually given as part of a combination of cancer medicines.

Avastin may also be used for purposes other than those listed here.

Most important: Avoid having surgery while you are being treated with Avastin. You may have problems with wound healing, which could result in bleeding or infection.

monoklonal antibodi anti VEGF

obat biologis

If you need to have any type of surgery, you will need to stop receiving Avastin for at least 4 weeks while your surgical incision heals.

Before being treated with Avastin, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, a history of stroke or blood clots, or an open wound.

Some people receiving a Avastin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Call your doctor at once if you have serious side effects such as blood in your stools or vomit, sudden numbness or weakness (especially on one side of the body), sudden headache or confusion, problems with vision or speech, chest pain spreading to the arm or shoulder, shortness of breath, swelling, rapid weight gain, or flu symptoms.

Avastin can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of Avastin, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

To be sure Avastin is not causing harmful effects, your blood pressure will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled visits to your doctor.








struktur antibodi

Avastin can affect a woman’s fertility (ability to have children). Talk to your doctor about your specific risks.

Kabar gembira, Terapi ajuvan Bevacizumab dapat menghambat perkembangan HER2-Negative Breast Cancer

Bevacizumab adalah antibodi monoklonal anti VEGF A (vascular endothelial growt factor A) yang sudah terbukti efektif untuk penderita ca mamae her-2 negatif metastasis. Dari hasil penelitian klinis terbaru yang dilaporkan oleh NEJM dengan judul “Neoadjuvant Chemotherapy and Bevacizumab for HER2-Negative Breast Cancer” membuktikan bahwa obat biologis ini juga efektif sebagai terapi ajuvan pada penderita ca mamae her-2 negatif fase awal yang diterapi dengan epirubisin, ciklofosfamid yang diikuti docetaxel. Harapan baru bagi penderita ca mamae fase awal yang selama ini belum bisa banyak berharap dengan sdiaan terapi yang sudah ada. Semoga hasil penelitian baru ini memberikan banyak manfaat pada masyarakat di Indonesia. Berminat membaca laporan lengkapnya? Silakan buka www.

Bagaimana penggunaan Neoajuvan Bevacizumab funtuk penderita breast ca dengan HER2-Negative

Bevacizumab adalah monoklonal antibodi anti vascular endotelial growt factor A (VEGF). Dari uji klinik sebelumnya terbukti bahwa bevacizumab efektif untuk penderita ca mamae her-2 negatif metastasis (stadium lanjut). Bagaimana kemanjuran penambahan bevacizumab untuk penderita ca mamae stadium awal yang diterapi epirubicin dan cyclophosphamide yang dilanjutkan dengan docetaxel belum diketahui. Laporan dari NEJM yang berjudul “Neoadjuvant Chemotherapy and Bevacizumab for HER2-Negative Breast Cancer

Jangan digunakan obat yang sudah kedaluwarsa, habis masa edar


kewapadaan dini terhadap obat

Don’t Be Tempted to Use Expired Medicines
By Sherunda Lister, Office of Communications

Woman reading prescription label

With curdled milk or petrified cucumbers it’s not hard to know when your food is past its prime, but how do you know when your medicine is past its prime?

Using expired medical products is risky and possibly harmful to your health. In the late 1970s, the U.S. Food and Drug Administration (FDA) began requiring an expiration date on prescription and over-the counter medicines. “Expiration dates on medical products are a critical part of determining if the product is safe to use and will work as intended,” says FDA pharmacist, Ilisa Bernstein. Sometimes following “EXP,” the expiration date can be found printed on the label or stamped onto the bottle or carton; it is important to know and adhere to the expiration date on your medicine.

Expired medical products can be less effective or risky due to a change in chemical composition or decrease in potency. Improper storage – such as a humid bathroom cabinet – can also contribute to decreased effectiveness in medicines that have not reached their posted expiration date. To help ensure the proper shelf life of your medicine, it is better to store medicine in a controlled climate.

If you have expired medicine, it should be disposed of properly. Read the label for disposal instructions that may be included.

If no instructions are provided, a drug take-back program, if available, is a good way to dispose of expired, unwanted or unused medicine. Check with your local government to see if there is a drug take-back program available in your area. If no take-back program is available, federal guidelines recommend throwing medicine away in the household trash by placing it in a bag or container and mixing with coffee grounds or kitty litter.

However, some medicine is specifically recommended for flushing down a toilet or sink because while safe and effective when used as prescribed, it could be especially harmful to a child, pet, or anyone else if taken accidentally. For a list of medicines recommended for disposal by flushing, as well as other information on proper disposal, please see the Disposal of Unused Medicines page.

“Once the expiration date has passed there is no guarantee that an expired medicine will be safe and effective,” says Bernstein. “If your medicine has expired, do not use it.”

info obat baru, obat antikanker ginjal diberikan ijin edar oleh FDA


For Immediate Release: Jan. 27, 2012
Media Inquiries: Stephanie Yao, 301-796-0394,
Consumer Inquiries: 888-INFO-FDA

FDA approves Inlyta to treat patients with a type of advanced kidney cancer
Drug helps keep cancer from progressing

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Renal cell carcinoma is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. Inlyta is a pill that patients take twice a day.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.

Inlyta is marketed by New York City-based Pfizer Inc.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.