TM Owner Mayne Pharma
Soltamox 10mg/5ml Oral Solution
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Indications & Clinical Uses
- Soltamox (tamoxifen citrate) oral solution, 10 mg/5 mL, is a selective oestrogen-receptor modulator taken by mouth once daily, giving a liquid alternative to tamoxifen tablets for people who have difficulty swallowing tablets.
- It is approved for the treatment of oestrogen-receptor-positive metastatic breast cancer, as adjuvant therapy after surgery for early-stage oestrogen-receptor-positive breast cancer, to reduce the risk of invasive breast cancer after ductal carcinoma in situ (DCIS), and to reduce breast cancer risk in adult women at high risk of developing the disease.
- It is used in both men and women where the relevant treatment indication applies, though the risk-reduction indications have been studied mainly in women.
- Soltamox and tamoxifen tablets contain the same active substance and are considered therapeutically equivalent at the same dose; Soltamox is manufactured and marketed in the US by Mayne Pharma.
Side Effects
- Soltamox carries a BOXED WARNING for serious, sometimes fatal events: uterine malignancies (endometrial cancer), stroke and pulmonary embolism occur more often on tamoxifen than on placebo in clinical trials.
- The most common side effects, reported in the majority of users, are hot flashes (about 80% in one prevention trial), mood changes, vaginal discharge or bleeding, nausea and fluid retention.
- Report any abnormal vaginal bleeding, pelvic pain or pressure promptly, since these can be early signs of uterine cancer.
- Seek emergency care for sudden leg swelling or pain, chest pain, breathlessness, sudden severe headache, weakness on one side of the body, or slurred speech, which can indicate a blood clot or stroke.
- Take Soltamox at about the same time each day, using the dosing cup provided, not a household spoon.
Precautions & Warnings
- Because of the boxed warning, tell your healthcare provider immediately about any abnormal vaginal bleeding, and have regular gynaecological checks while taking Soltamox, especially when it is used for risk reduction rather than to treat existing cancer.
- Soltamox is contraindicated in people who require concurrent warfarin therapy or who have a history of deep vein thrombosis or pulmonary embolism when used for the DCIS or risk-reduction indications.
- Tamoxifen can cause fetal harm, so effective non-hormonal contraception is required during treatment and for at least 2 months after the last dose; breastfeeding should be avoided during treatment and for 3 months afterward.
- Liver function should be monitored periodically.
- Discuss any planned surgery well in advance because of the clotting risk.
- Soltamox is for oral use only and each dose should be measured with the dosing cup supplied.
Avoid Interactions
- Do not take Soltamox together with anastrozole or letrozole (aromatase inhibitors), as combining them is not recommended.
- Strong CYP3A4-inducing drugs, such as rifampin, can lower tamoxifen levels and may reduce its effectiveness.
- If you also take warfarin or another anticoagulant for cancer treatment, your clotting (INR) must be monitored more closely, since tamoxifen can increase anticoagulant effect and bleeding risk.
- The effect of CYP2D6-inhibiting drugs, such as the antidepressants paroxetine and fluoxetine, on tamoxifen's efficacy is uncertain but such combinations are generally avoided where a suitable alternative exists, since these drugs may reduce conversion of tamoxifen to its active form.
- Tell your healthcare provider and pharmacist about every medicine, herbal product and supplement you take, and mention Soltamox before starting anything new.
References
Frequently Asked Questions
Soltamox (tamoxifen citrate) oral solution treats oestrogen-receptor-positive breast cancer, is used after surgery to help prevent recurrence, and reduces breast cancer risk after DCIS or in women at high risk. It contains the same active ingredient as tamoxifen tablets, in a liquid form.
Take Soltamox (tamoxifen citrate) by mouth once daily, using the dosing cup provided, at about the same time each day, with or without food. The usual dose is 20 mg (10 mL), but your healthcare provider will confirm the right amount for you.
Common side effects of Soltamox (tamoxifen) include hot flashes, mood changes, vaginal discharge or bleeding, and nausea. It has a boxed warning for uterine cancer, stroke and blood clots in the lungs. Report any abnormal vaginal bleeding, leg swelling, chest pain or sudden weakness right away.
Avoid combining Soltamox with anastrozole or letrozole. Avoid strong CYP3A4 inducers like rifampin, which can weaken tamoxifen's effect. Use effective non-hormonal contraception, since Soltamox can harm an unborn baby, and avoid breastfeeding during treatment and for 3 months after your last dose.
If you miss a dose of Soltamox, take it as soon as you remember that day; skip it if it's nearly time for your next dose, and never double up. Store the bottle at room temperature, away from light, and discard any leftover solution 3 months after opening.
Treatment length depends on why Soltamox (tamoxifen) is prescribed: adjuvant treatment after breast cancer surgery is typically 5 to 10 years, while risk-reduction use is often around 5 years. Your healthcare provider will set your specific duration and review it regularly.
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