Ganirelix Inhalational Liquid 0.25mg/0.5ml Taj Pharma

  1. Name of the medicinal product

ganirelix 0.25 mg/0.5 ml solution for injection in pre-filled syringe.

  1. Qualitative and quantitative composition

Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml aqueous solution.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection in pre-filled syringe.

Clear and colourless aqueous solution with a pH between 4.5 to 5.5 and an osmolality between 250 to 350 mOsm/kg.

  1. Clinical particulars

4.1 Therapeutic indications

Ganirelix is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

In clinical studies, ganirelix was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.

4.2 Posology and method of administration

Ganirelix should only be prescribed by a specialist experienced in the treatment of infertility.

Posology

Ganirelix is used to prevent premature LH surges in women undergoing COH. Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses. Ganirelix (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa. The starting day of ganirelix is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of ganirelix may be delayed in absence of follicular growth, although clinical experience is based on starting ganirelix on day 5 or day 6 of stimulation.

Ganirelix and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites are to be used.

FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).

Daily treatment with ganirelix should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).

Timing of last injection

Because of the half-life of ganirelix, the time between two ganirelix injections as well as the time between the last ganirelix injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur. Therefore, when injecting ganirelix in the morning, treatment with ganirelix should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation. When injecting ganirelix in the afternoon the last ganirelix injection should be given in the afternoon prior to the day of triggering ovulation.

Ganirelix has shown to be safe and effective in women undergoing multiple treatment cycles.

The need for luteal phase support in cycles using ganirelix has not been studied. In clinical studies, luteal phase support was given according to study centres’ practice or according to the clinical protocol.

Special populations

Renal impairment

There is no experience on the use of ganirelix in subjects with renal impairment, as they were excluded from clinical studies. Therefore, the use of ganirelix is contraindicated in patients with moderate or severe renal impairment (see section 4.3).

Hepatic impairment

There is no experience on the use of ganirelix in subjects with hepatic impairment, as they were excluded from clinical studies. Therefore, the use of ganirelix is contraindicated in patients with hepatic impairment (see section 4.3).

Paediatric population

There is no relevant use of ganirelix in the paediatric population.

Method of administration

Ganirelix should be administered subcutaneously, preferably in the upper leg. The injection site should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of ganirelix themselves, provided that they are adequately instructed and have access to expert advice.

4.3 Contraindications

– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

– Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue

– Moderate or severe impairment of renal or hepatic function

– Pregnancy or breast-feeding.

4.4 Special warnings and precautions for use

Hypersensitivity reaction

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions have been reported, as early as with the first dose, during post-marketing surveillance (see section 4.8). In the absence of clinical experience, ganirelix treatment is not advised in women with severe allergic conditions.

Ovarian hyperstimulation syndrome (OHSS)

Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

Ectopic pregnancy

Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Congenital malformations

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations. In clinical studies investigating more than 1000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using ganirelix is comparable with that reported after COH treatment using a GnRH agonist.

Women weighing less than 50 kg or more than 90 kg

The safety and efficacy of ganirelix have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).

This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of ganirelix in pregnant women.

In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3). The relevance of these data for humans is unknown.

Breast-feeding

It is not known whether ganirelix is excreted in breast milk.

The use of ganirelix is contraindicated during pregnancy and breast-feeding (see section 4.3).

Fertility

Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.

For posology and method of administration, see section 4.2.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Summary of the safety profile

The table below shows all adverse reactions in women treated with ganirelix in clinical studies using recFSH for ovarian stimulation. The adverse reactions with ganirelix using corifollitropin alfa for ovarian stimulation are expected to be similar.

Tabulated list of adverse reactions

The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100). The frequency of hypersensitivity reactions (very rare, <1/10,000) has been deduced from post-marketing surveillance.

System organ class Frequency Adverse reaction
Immune system disorders Very rare Hypersensitivity reactions (including various symptoms such as rash, facial swelling and dyspnoea)1

Worsening of a pre-existing eczema2

Nervous system disorders Uncommon Headache
Gastrointestinal disorders Uncommon Nausea
General disorders and administration site conditions Very Common Local skin reaction at the site of injection (predominantly redness, with or without swelling)3
Uncommon Malaise

1 Cases have been reported, as early as with the first dose, among patients administered ganirelix.

2 Reported in one subject after the first ganirelix dose.

3 In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in ganirelix treated patients and 25 % in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration.

Description of selected adverse reactions

Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

By reporting side affects you can help provide more information on the safety of this medicine.

4.9 Overdose

Overdose in humans may result in a prolonged duration of action.

No data on acute toxicity of ganirelix in humans are available. Clinical studies with subcutaneous administration of ganirelix at single doses up to 12 mg did not show systemic adverse reactions. In acute toxicity studies in rats and monkeys’ non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.

In case of overdose, ganirelix treatment should be (temporarily) discontinued.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin releasing hormones,

Mechanism of action

Ganirelix is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists. Following administration of multiple doses of 0.25 mg ganirelix to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74 %, 32 % and 25 % at 4, 16 and 16 hours after injection, respectively. Serum hormone levels returned to pre-treatment values within two days after the last injection.

Pharmacodynamic effects

In patients undergoing controlled ovarian stimulation the median duration of ganirelix treatment was 5 days. During ganirelix treatment the average incidence of LH rises (>10 IU/l) with concomitant progesterone rise (>1 ng/ml) was 0.3 – 1.2 % compared to 0.8 % during GnRH agonist treatment. There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (>80 kg), but no effect on clinical outcome was observed. However, based on the small number of patients treated so far, an effect cannot be excluded.

In case of a high ovarian response, either as a result of a high exposure to gonadotrophins in the early follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier than day 6 of stimulation. Initiation of ganirelix treatment on day 5 can prevent these premature LH rises without compromising the clinical outcome.

Clinical efficacy and safety

In controlled studies of ganirelix with FSH, using a long protocol of GnRH agonist as a reference, treatment with the ganirelix regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol. This different pattern of follicular growth requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol. Similar comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol have not been performed.

5.2 Pharmacokinetic properties

Pharmacokinetic parameters after multiple subcutaneous dosing of ganirelix (once daily injection) were similar to those after a single subcutaneous dose. After repeated dosing 0.25 mg/day steady-state levels of approximately 0.6 ng/ml were reached within 2 to 3 days.

Pharmacokinetic analysis indicates an inverse relationship between bodyweight and serum concentrations of ganirelix.

Absorption

After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/ml within 1 to 2 hours (tmax). The bioavailability of ganirelix following subcutaneous administration is approximately 91 %.

Biotransformation

The major circulating component in plasma is ganirelix. Ganirelix is also the main compound found in urine. Faeces only contain metabolites. The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites. The metabolite profile of ganirelix in humans was similar to that found in animals.

Elimination

The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 l/h. Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %).

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.

Reproduction studies carried out with ganirelix at doses of 0.1 to 10 µg/kg/day subcutaneously in the rat and 0.1 to 50 µg/kg/day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups. No teratogenic effects were observed.

  1. Pharmaceutical particulars

6.1 List of excipients

Acetic acid, glacial

Mannitol

Water for injection

The pH may have been adjusted with sodium hydroxide and acetic acid, glacial.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Pre-filled syringes made of colorless type I glass containing 0.5 ml of sterile, ready for use, aqueous solution closed with the grey rubber plunger stopper and polypropylene plunger rod. Injection needles (27 G) affixed to the barrel and provided with grey elastomeric needle shield and polypropylene rigid needle shield.

Supplied in cartons containing 1 or 5 pre-filled syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Ganirelix Acetate Injection 0.25mg/0.5ml Taj Pharma

Package leaflet: Information for the user

Ganirelix Acetate Injection 0.25 mg/0.5 ml solution for injection in pre-filled syringe

ganirelix

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Ganirelix Acetate Injection is and what it is used for
    2. What you need to know before you use Ganirelix Acetate Injection
    3. How to use Ganirelix Acetate Injection
    4. Possible side effects
    5. How to store Ganirelix Acetate Injection
    6. Contents of the pack and other information

 

  1. What Ganirelix Acetate Injection is and what it is used for

Ganirelix Acetate Injection contains the active substance ganirelix and belongs to a group of medicines called “anti-gonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH). GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)). Gonadotrophins play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. LH is needed to release the mature egg cells from the follicles and ovaries (i.e. ovulation). Ganirelix Acetate Injection inhibits the action of GnRH, resulting in suppression of the release of especially LH.

Ganirelix Acetate Injection is used for

In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant. Ganirelix Acetate Injection is used to prevent the premature LH surge that might cause such a premature release of egg cells.

In clinical studies ganirelix was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.

  1. What you need to know before you use Ganirelix Acetate Injection

Do not use Ganirelix Acetate Injection

  • if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6)
  • if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue
  • if you have a moderate or severe kidney or liver disease
  • if you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before using Ganirelix Acetate Injection

  • if you have an active allergic condition, please tell your doctor. Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. Cases of allergic reactions have been reported, as early as with the first dose.
  • during or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. This syndrome is related to the stimulation procedure with gonadotrophins. Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
  • the incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using Ganirelix Acetate Injection is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
  • there is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.
  • the efficacy and safety of Ganirelix Acetate Injection has not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

Children and adolescents

There is no relevant use of Ganirelix Acetate Injection in children or adolescents.

Other medicines and Ganirelix Acetate Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines.

Pregnancy, breast-feeding and fertility

Ganirelix Acetate Injection should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Ganirelix Acetate Injection during pregnancy and breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The effects of Ganirelix Acetate Injection on ability to drive and use machines have not been studied.

Ganirelix Acetate Injection contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially “sodium-free”.

  1. How to use Ganirelix Acetate Injection

Ganirelix Acetate Injection is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF).

You will be giving yourself the injections and so your doctor will explain what you have to do. Always use this medicine exactly as your doctor or pharmacist has told you. If you have not understood the instructions check with your doctor or pharmacist.

Stage 1

Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period.

Stage 2

The content of the syringe Ganirelix Acetate Injection (0.25 mg) should be injected just under the skin once daily, starting on day 5 or day 6 of stimulation. Based on your ovarian response, your doctor may decide to start on another day.

Ganirelix Acetate Injection and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites must be used.

Daily treatment with Ganirelix Acetate Injection should be continued up to the day that sufficient follicles of adequate size are present.

Stage 3

Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG). The time between two Ganirelix Acetate Injection injections as well as the time between the last Ganirelix Acetate Injection injection and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur. Therefore, if you have been injecting Ganirelix Acetate Injection in the morning you must also have Ganirelix Acetate Injection on the day when you will receive the hCG treatment to trigger ovulation. If you have been injecting Ganirelix Acetate Injection in the afternoon the last Ganirelix Acetate Injection injection should be given in the afternoon prior to the day of triggering ovulation.

Instructions for use

Injection site

Ganirelix Acetate Injection is supplied in pre-filled syringes which contain one dose. The contents should be injected slowly, just under the skin, preferably in the upper leg. Inspect the solution before use. Do not use if the solution contains particles or is not clear. If you administer the injections yourself or have it done by your partner, follow the instructions below carefully. Do not mix Ganirelix Acetate Injection with any other medicines.

Preparing the injection site

Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria. Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.

Inserting the needle

Remove the needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface. Use a different place for each injection.

Checking the correct needle position

Gently draw back the plunger of the syringe to check if the needle is positioned correctly. If any blood is drawn into the syringe it means the needle tip has penetrated a blood vessel. If this happens, do not continue with the injection of Ganirelix Acetate Injection. Remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Removing the syringe

Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.

Use the pre-filled syringe only once.

If you use more Ganirelix Acetate Injection than you should

Contact your doctor.

If you forget to use Ganirelix Acetate Injection

If you realise that you forgot a dose, administer it as soon as possible.

Do not inject a double dose to make up for a forgotten dose.

If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice.

If you stop using Ganirelix Acetate Injection

Do not stop using Ganirelix Acetate Injection unless advised to by your doctor, as this may affect the outcome of your treatment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

  • local skin reactions at the site of injection (predominantly redness, with or without swelling). The local reaction normally disappears within 4 hours of administration.

Uncommon (may affect up to 1 in 100 people)

  • headache
  • nausea
  • malaise (general feeling of being sick, feeling bad).

Very rare (may affect up to 1 in 10,000 people)

  • more widespread possibly allergic reactions have been observed as early as with the first dose.

In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment, e.g.:

  • abdominal pain
  • ovarian hyperstimulation syndrome (OHSS). (OHSS happens when your ovaries overreact to the fertility medicines you’re taking.)
  • ectopic pregnancy (when the embryo develops outside the womb)
  • miscarriage (see the patient information leaflet of the FSH-containing preparation you are treated with).

Worsening of a pre-existing rash (eczema) has been reported in one subject after the first ganirelix dose.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store Ganirelix Acetate Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Ganirelix Acetate Injection contains

  • The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg ganirelix (as acetate) in 0.5 ml aqueous solution.
  • The other ingredients are acetic acid, glacial, mannitol and water for injection. The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid, glacial.

What Ganirelix Acetate Injection looks like and contents of the pack

Ganirelix Acetate Injection is a clear and colourless aqueous solution for injection. The solution is ready for use and intended for subcutaneous administration.

Ganirelix Acetate Injection is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G).

Not all pack sizes may be marketed.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com