Diphereline P.R. 11.25mg Ipsen treatment of prostate cancer, endometriosis

Studies performed in humans and animals show that, after the initial stimulus, the prolonged use of Triptorelin will inhibit the excretion of genital hormones and the result of inhibiting the function of testicular and ovaries.

Triptorelin Diphereline P.R 11.25 mg injection may increase the level of LH & FSH levels in the blood and result in increased testosterone levels (Flare-up) in men and oestradiol levels in women. Continuing to treat triptorelin reduces the level of LH & FSH, resulting in a decrease in the level of testosterone and oestradiol to reach the cutting threshold within 20 days after the injection and last until the drug is still used.

Prolonged treatment with Triptorelin inhibits oestradiol secretion in women and thus stopping the development of endometriosis.

A random phase study of 970 patients with prostate cancer progresses on the spot (T2C-T4) to evaluate the evaluation of radiation therapy in combination with short-term androgen inhibitors (6 months, n = 483) is inferior (Non-inferior) Radiotherapy combined with long-term Androgen inhibitors (3 years, n = 487) or not. Other GNRHs (37.8%) and non -decentralized research in each type of co -type.

Post -testing analysis (post) in the group using triptorelin also pointed out the advantages of long -term treatment compared to short -term treatment on the general mortality rate (risk ratio 1.28; 95.71% CI = [0.89; 1.84], P = 0.38 and P = 0.08 corresponding to the following testing is not lower and for the difference between treatment groups).

This study indicates that radiation therapy combined with long -term (3 -year) inhibitors (3 years) is better than the combination of radiation therapy and short -term Androgen inhibitors (6 months).

in children - Wire early

Excessive inhibition of the genital hormone of the pituitary gland in both sexes, showing the inhibition of oestradiol secretion or testosterone, lowering the peak of the lii and improving the age/bone age ratio.

Stimulating sex hormones can cause mild sexual bleeding that needs medexyprogesterone or cyproterone acetate.

Dynamic pharmacokinetics

After intramuscular injection of Diphereline P.R 11.25 mg for patients (male & female), Triptorelin reaches the peak concentration of plasma about 3 hours after injection. This concentration decreases in the first month and maintains up to the end of the 3rd month after injection.

Some sporadic cases, symptoms of more severe metastasis such as urinary tract obstruction or pulp. Therefore, patients with metastatic spine damage and/or blockage of upper or lower urinary tract should be closely monitored in the first weeks of treatment.

Use of gnrh co -transportation to treat prostate cancer may be related to bone loss and can lead to osteoporosis and the risk of fractures.

Increased lymphocytes have been reported in patients treated with similar substances GNRH. The secondary increase in lymphocytes is clearly related to testicular cutting with gnrh in the same time and suggests that the sex hormones associated with the atrophy of the thymus.

Patients with long -term treatment with the same substance GNRH in combination with radiation may have more side effects, especially the stomach, related to radiation therapy.

Women's tolerance

As a result of decreased estrogen levels, the most common harmful reactions are reported (≥ 10%): headache, decreased libido, sleep disorders, mood changes, pain intercourse, menstruation, genital bleeding, ovarian hypertrophic syndrome, pelvic hypertrophy, abdominal pain, vaginal vaginal pain, sweat -increasing sweat.

The harmful reactions have been reported below, considered at least may be related to Triporelin treatment. Most of them are known to be related to ovarian cutting by surgery or medication.

The frequency of harmful reactions is classified as follows:

Very often (≥ 1/10)

Vaginal bleeding may occur in the month after the first injection.

Notice the unwanted effects when using the drug.

Be cautious when using

Use of gnrh co -transport can cause reducing bone density. Initial figures suggest that men using bisphosphonate in combination with the gnrh can reduce bone loss. It is necessary to be especially cautious in patients with more risk factors for osteoporosis (chronic alcoholism, smoking, long -term treatment with drugs that reduce bone density: anticonvulsants or corticosteroids, family history with osteoporosis, malnutrition).

Make sure the patient is not pregnant before prescribing Diphereline P.R. 11.25mg. When treated with gnrli, it is rarely possible to reveal the pituitary gland gonadotrophin tumor that previously unknown. These patients may manifest a hemorrhage or pituitary infarction with clinical manifestations: sudden headache, vomiting, vision disorders, eye paralysis.

There is an increase in the risk of depression (maybe severe) in patients who are being treated with GNRH Dong Van, such as Triptorelin. Patients must be informed and treated appropriately if symptoms.

Patients with depression must be closely monitored during treatment. Diphereline P.R. 11.25mg contains less than 1 mmol Na (23 mg) in 1 dose, which is considered to contain no Na.

Be cautious in patients treated with anticoagulant drugs because there may be risk of hematoma at potential points.

Prostate cancer

When starting treatment, Triptorelin, as well as other gnrh, causes increased serum testosterone levels. This can lead to some single cases of signs and symptoms of prostate cancer temporarily worse during the first weeks of treatment. In the therapeutic phase, it is advisable to consider using an appropriate androgen resistance to resist the increase in testosterone levels and the aggravation of clinical symptoms.

A few patients with temporary severity of the signs and symptoms of prostate cancer and temporary increase in cancer -related pain (metastatic pain) can be controlled by symptomatic medication.

As well as other GNRHs, some single cases have pulp or obstruction of the urethra that have been observed. If you have pulp or kidney failure, you must apply standard treatments for these signs, in extremely severe cases, you must consider cutting testicles under the bag (surgical testicular cutting). Closely monitor in the first weeks of treatment, especially in patients with spinal metastases, at risk of pulp, and in patients with urinary tract congestion. For the same reason, especially when starting treatment in patients with millions of pulp.

After testicular surgery, Triptorelin does not reduce the concentration of testosterone in the blood further.

Long -term Androgen secretion or testicular surgery on both sides or due to the use of the same substance as GNRH increases the risk of bone loss and can lead to osteoporosis and increase the risk of bone.

Androgen supplement (Androgen suppression) can cause a QT range. In patients with a history or a risk factor that extends the QT and in patients treated with drugs that can extend the QT range, the doctor must assess the benefits/risk, including the risk of torsion before starting treatment with diphereline.

Triptorelin injection at the treatment dose leads to the inhibition of pituitary -gonads. Normal function will recover after stopping treatment. Therefore, the diagnostic test of the pituitary function during and after treatment with the same substance may be deviated from the results. Can increase transient phosphatase acid in the first stage of treatment.

Should regular testosterone in the blood by the exact method, the results must not exceed 1 ng/ml.

In women

Make sure the patient is not pregnant before prescribing Diphereline P.R 11.25 mg.

Use of the gnrh can reduce the average bone density of 1% per month for 6 months of treatment. Each 10% of bone density decreases associated with increased risk of fractures 2 to 3 times.

In most women, the current figures suggest that bone loss after stopping the tri. There are currently no data on patients who have had osteoporosis or risk factors for osteoporosis (such as chronic alcoholism, smoking, long -term treatment with drugs that reduce bone density such as anticonvulsants, corticosteroids, families with a history of osteoporosis, poor nutrition such as neurological anorexia). Because bone density reduction will be more detrimental in these patients, Triptorelin treatment must be considered in each specific patient and only treated if the benefits are risky after careful evaluation. Must consider using more measures against bone loss.

Regular injection of Diphereline P.R 11.25 mg causes amenorrhea due to reduced gonadotrophin.

If genital bleeding occurs after the first month, the amount of estradiol concentration should be quantified, if the concentration Due to the lack of menstruation while treating with triptorelin, the patient should be instructed to notify the doctor if you still have menstruation.

Patients should use contraception not equal to drugs during the treatment process including 1 month after the final injection. After stopping the drug, the winning chamber function will return and ovulation occurs about 5 months after the final nasal injection.

Early puberty

Treatment in children with progressive brain tumors should be carefully considered based on the benefits and risks of each individual.

In girls, in the first month of the initial treatment is to stimulate the ovaries and then reduce the estrogen levels that show vaginal bleeding with mild or moderate level.

After stopping treatment, the development of the characteristics will occur. Information related to reproduction in women who are treated with the same substance GNRH in childhood is still limited. Most of the girls, the menstrual cycle will start on average a year after stopping treatment.

Diphereline P.R 11.25 mg does not specify early puberty less progression or self -regression, partial puberty (early development of pubic hair, early mammary development) and have a single menstrual period with or without developing the mammary glands with the heterogeneous response code with LHRH stimulation test and the presence of function follicles.

Eliminate early puberty (tumor or adrenal hyperplasia, tumor or increase in gonads) and early puberty regardless of gonadotrophin (testicular toxicity, hyperplasia leydig cell properties).

Bone density (BMD) can be reduced when treating early puberty with GNRH. However, after stopping treatment of the remaining bone mass is preserved and the maximum bone volume at the end of the youth period does not seem to be affected by treatment.

Sliding the femoral head can be seen after stopping the treatment of GNRH. According to the theory of low estrogen during the treatment of gnrh co -movement, the cartilage is weakened with bone tip (growth cartilage). The increase in the growth of growth after stopping treatment leads to a decrease in sliding force needed for the movement of the bone tip.

The effect of drugs on driving and operating machinery

There is no research on the effect of driving and operating machinery. However, the ability to drive and operate machinery may be reduced due to the unwanted effects of the drug or the result of the hidden disease such as dizziness, chicken sleep and visual disorders.

Use drugs for women during pregnancy and lactation

Pregnant women

Should eliminate pregnancy before prescribing Diphereline. Triptorelin should not be used during pregnancy because of the theoretical risk of miscarriage or fetal malformations related to the use of gnrh transport during pregnancy. Before treatment, pregnant women should be carefully tested to eliminate pregnancy. Do not take non -drug contraceptive measures to contain hormones during treatment until menstruation.

breastfeeding women

Women who are breastfeeding should not use triptorelin.

Drug interaction

must be particularly cautious when Triptorelin is used with drugs that change the excretion of the genital hormones of the pituitary gland and recommend closely monitoring through hormone quantitative tests.

The fact that Androgen inhibitors can cause a QT range, must be carefully evaluated when used simultaneously with diphereline with known drugs that cause QT interval or drugs that can cause adhesion such as anti -arrhythmia IA (quinidine, disopyramide) or group III (Amiodarone, Sotalol, Dotetilide, IButilide), Methadide), Methadone), Methadone), Methadone) moxifloxacin, anti -psychotic drugs.